harold_cv052015

version R05 of 05/2015
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Harold Ikechukwu Emordi
swiss pharma nigeria Limited, 5, Dopemu Road, Agege. P.O. Box 463, Ikeja. Lagos. Nigeria.
Phone: +234 8103211640, +2348090486781
harold.emordi@swiphanigeria,com
OBJECTIVE
To manage, lead, or participate on a short, medium or long-term projects within the FDA regulated
industries on Documentation, System Set Up and Enhancements, Dossier preparation, Quality Control,
Quality Assurance, Preparations and Reviews, Auditing, Method and Process Validations, Workflow
Analysis and Efficiency Enhancement Project, Stability Studies, Equipment and Facility Qualification,
Project Management.
SKILLS AND EXPERTISE
 Over 18 years of versatile, industrial experience in various areas of the pharmaceutical industry
with companies such as Super-Link Pharmacy Limited, Roche Nigeria Limited, swiss pharma
nigeria Limited and Vaccine Production Laboratory (Federal Ministry of Health, Lagos, Nigeria).
 Over 6000 hours of PMP.
 Excellent interpersonal, communication (written and oral), managerial, problem solving and
analytical skills. Strong project planning and implementation skills
 Ability to adapt to multiple task functions effectively without losing focus.
 Familiar with various manufacturing processes, process and cleaning validations, water system
qualification, documentation systems, SOPs, cGMP, GLP, GDP, FDA and WHO regulations.
 Vast experience with reviews (APQR, Management reviews), Vendor Selection and Evaluation,
Self Inspection, Quality Auditing (including API manufacturers audit)
 Very familiar with various monographs and general chapters of USP/NF, EP, other compendium
and industry standards.
 Well versed in modern instrumentation such as HPLC, GC, AAS, UV, FTIR, etc, as well as various
other analytical techniques.
 Experienced in various dosage forms such tablets, liquids, suspensions, gels and sterile products
(vaccines).
 Well versed in generation, maintenance and revision of SOPs, specifications, procedures,
protocols, batch records, training, OOS investigations, product release, product development,
change management and other documentation systems.
 Wide exposure to quality control, quality assurance, manufacturing, validations, dossier
preparation, Mapping, and compliance in pharmaceutical manufacturing environment.
 Experienced in management of Deviations, Complaints, Recalls, Risk Management and CAPA.
 Experienced in Quality Management System (ISO 9000) and Environmental Management System
(ISO 14001) including audits.
 Proficiency in the development of Quality Agreement, process improvement, preparation of
water manual, project management and environmental monitoring.
 Knowledge Management, Team Leadership, Leadership Development, Operations Management
Strategic Planning, Team Management
 Proficient with common computer software and SAP All in One.

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PROFESSIONAL ASSOCIATIONS
1. Member, American Society of Project Management Professionals
2. Member of the American Society for Quality (ASQ)
3. Member of the Institute of Chartered Chemists of Nigeria
4. Member of the Institute of Public Analysts of Nigeria
EDUCATION
1. Masters Degree in Business Administration (Strategic Management) 2011, Wisconsin
International University, USA.
2. Higher National Diploma in Biochemistry 1993, Yaba College of Technology, Lagos, Nigeria.
3. National Diploma in Science Technology 1990, Yaba College of Technology, Lagos, Nigeria.
PROFESSIONAL QUALIFICATION
1. Advanced Auditor, ISO 14001 Environmental Management System (2009)
2. Certified Auditor, ISO 14001 Environmental Management System (2008)
3. Lead Auditor, ISO 9001 Quality Management System (2006)
4. Certified ISO 9000 Documenter and Internal Auditor - QMS (2005)
5. Certified Public Analyst (2005)
6. Chartered Chemist (2007)
7. Certified Project Management Expert (2014)
EMPLOYMENT
1. Quality Manager May 2015 - Date
swiss pharma nigeria Limited
5, Dopemu Road, Agege, Lagos.
Responsibilities:
1. Batch release for placement on the market in line with the marketing authorization.
2. To ensure that qualification and quality control equipment, validation processes, cleaning of
production equipment, utilities and analytical methods are planned for by liaising with other
stakeholders in drawing up a qualification/validation master plan {Q/VMP) and subsequently
ensuring that the qualification and validation process are carried out according to the Q/VMP.
3. To liaise with other stakeholders in preparing the Site Master File.
4. Organizing/carrying out of QMS and GMP related trainings in conjunction with the technical
manager.
5. Organizing/carrying out of self inspection and external audits.
6. Management of recall of products, out of specification results and deviations as well as change
control affecting quality of products.
7. To ensure that all necessary tests are carried out before release of any product.
8. To ensure the processing of product complaints according to WHO cGMP guidelines and ISO
9001:2008 standards.
9. To evaluate the results of accelerated and follow up stability studies.
10. To ensure that annual product quality review and trend analysis is carried out.
11. To ensure in liaison with other stakeholders that rejected or defective materials or products are
disposed according to country specific rules and regulations.

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12. To ensure proper documentation, storage and retrieval of all Quality-related documents
according to swipha guidelines.
13. To ensure discipline of QA/QC/R&D personnel in conjunction with the technical manager.
14. To ensure that purchase of QC/QA/R&D job specific materials are adequately monitored.
15. To ensure that placement of logo, colour conformances on materials for promotional activities
are released after proof reading and approval of text and content by Head of Pharma, Regulatory
Affairs and Product Manager respectively.
16. To check that new medicinal products developed by swipha meet GMP standards.
17. To check that packaging materials are designed and approved according to country specific
guidelines.
18. To qualify new suppliers and contract acceptors and re-audit existing contract acceptors.
19. Carry out the duties of Management Representative according to the requirements of ISO
9001:2008 Quality Management System guidelines.
20. Review of stability data reports.
21. Work closely with the technical manager to ensure that the department meets its strategic goal
and objectives.
22. Ensure the technical manager is kept informed of any trend or changes which may have
significant effect on product quality.
23. To ensure adequate and effective communication system within and without the department.
2. Senior System Compliance Manager September 2005 – April 2015
Responsibilities:
1. Perform Batch Record review.
2. Assist in qualification of production and quality control equipment, process validation,
cleaning validation of production equipment, utilities and analytical methods validations by
liaising with other stakeholders in drawing up a qualification/validation master plan and
subsequently ensuring that the VMP is implemented.
3. To liaise with other stakeholders in preparing the Site Master Plan.
4. Management of manufacturing deviations, OOS and investigations.
5. Review of stability protocols and stability data reports.
6. Support QMS and cGMP trainings and awareness.
7. Carry out self- inspection and external audits.
8. Develop audit plan for company-wide cGMP and QMS audits.
9. Review all cGMP related technical documents.
10. Lead sub-system improvement teams (Risk Management, Validation, Qualification,
Deviation, Change Control, CAPA e.t.c).
11. Analyse Quality sub-system compliance requirements, identify gaps and lead efforts to
address the gaps.
12. Carry out Annual Product Quality Reviews and trend analyses.
13. Responsible for reviewing, preparing and overseeing all aspects of swipha quality
compliance.
14. Providing disposition of and implementing corrective action to out of compliance situations.

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15. Provide leadership and expertise in the maintenance and continuous improvement of the
quality system.
16. Assure proper documentation, storage and retrieval of all quality related documents
according to swipha guidelines.
17. Create internal quality audit teams and drive team performance.
18. Enforce adequate cGMP observance in the laboratory and plant.
19. Demonstrate the understanding of the application of the quality policy through daily
activities.
20. Oversee the activities of the QA and Documentation section.
21. Provide necessary data and other technical information required to assess, review and give
disposition on all problem batches in conjunction with the Quality Manager.
22. Assist in the qualification of new suppliers and contract acceptors as well as re-audit of
existing contract acceptors.
23. Participate in organizing inspection and quality audit of packaging material suppliers.
24. Coordinate and assess the effectiveness of cGMP training for new and existing staff in
conjunction with their departmental heads.
25. Write or review SOPs relevant to our operations.
26. Support change control system by providing guidance to documents/system owners to
ensure systems and changes remain compliant.
27. Work closely with the quality manager to ensure that the department meets its strategic
goals and objectives.
28. Ensure that rejected or defective materials or products are disposed according to country
specific rules and regulations.
29. Ensure that starting materials and products are stored in swipha warehouse according to
cGMP guidelines.
30. Ensure the purchase of QC/QA job specific materials are monitored.
3. Internal Auditor (Quality Systems) July 2003 – September 2005
Responsibilities:
1. Assist Management in QMS formulation.
2. Selection and designing of appropriate mode of QMS for implementation.
3. Ensure implementation and maintenance of ISO 9001:2000 requirements.
4. Assist in planning and execution of quality audits.
5. Prepare a summary of updates for management review.
6. Assist in the establishment and maintenance of a cross-functional project management
teams.
7. Provide QMS assurance and management reporting services as required.
8. Assist in planning and conducting quality assessment of products/services.
9. Attend to any other duties as may be assigned from time to time.

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4. Quality Assurance Officer September 2001 – July 2003
Responsibilities:
1. Maintain appropriate effective documentation to control the receipt and release of
imported finished goods.
2. Provide effective compliance inspection of all pharmaceutical lines and processes and other
support activities that have significant impact on product quality.
3. Carry out inspection disposition of all returned goods and recommend appropriate
disposition to quality manager in accordance with relevant swipha policies and standard
operating procedures.
4. Develop appropriate effective documentation to control the receipt and release of all
packaging materials.
5. Ensure adequate inspection, sampling and proof reading of all printed packaging materials,
product inserts and brochure according to the relevant SOPs and swipha quality
specifications.
6. Provide effective in-process control checks of all pharmaceutical production lines and
processes according to relevant SOPs.
7. Validation of manufacturing processes and ensures adequate collation and reporting of
data.
8. Quality audit of local suppliers and printers.
9. Review all batch processing records for final release of products for sale.
10. Carry out adequate water monitoring exercise of swipha process and portable water.
11. Environmental and personnel monitoring.
12. Carry out self inspection.
13. Equipment qualification.
14. Ensure adequate inspection of all miscellaneous and promotional materials before release
for use.
15. Write or update all SOPs relevant to our operations.
16. Carry out stability studies/testing (accelerated and long term) on products as may be
required.
17. Ensure adequate cGMP observations in the plant.
18. Give back up/support for microbiological test/analysis.
19. Chemical analysis of routine products and raw materials.
20. Assist in the development of new products.
21. Training of interns and industrial attachees.
5. Chemical Analyst August 1999 – August 2001
Responsibilities:
Ensure that all drugs manufactured, imported and marketed by swiss pharma nigeria Ltd are
fully analyzed and in compliance with RI and National Regulatory requirement before they are
released for sale.

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Ensure that all raw materials locally supplied by third party via importation or imported
from F. Hoffmann – La Roche Limited are fully analyzed and in compliance with RI and
National specification before they are released for use.
Carry out sampling of all raw materials, finished products, intermediates and validation
samples
in accordance with SOP.
Carry out dissolution testing of finished products.
Ensure stock taking of laboratory chemicals and wares.
Maintain appropriate trend data for finished products and assist in data evaluation to
ensure product quality and review product quality from time to time.
Validation of manufacturing and analytical processes and ensures that adequate collation and
reporting of data is carried out.
Assist in the development of alternative analytical
procedures. Writing and review of all SOPs.
Ensure adequate calibration of all functional laboratory equipment.
Standardization of chemicals.
Carry out stability testing (accelerated, long term and / or follow up) of products as may be
required.
Effluent
analysis.
Carry out chemical analysis of water.
Ensure that GLP guidelines are adhered to in the control laboratory.
Ensure that retention samples for each batch of starting materials, APIs, and finished
products are collected and stored according to SOP.
Establish an effective/efficient method of storage and retrieval of quality control batch
documentation and retained samples.
6. Liquid Line Superintendent March 1997 – July 1999
Roche Nigeria Limited
5, Dopemu Road , Agege , Lagos.
Responsibilities:
1. Coordination of liquid manufacturing activities.
2. Liquid manufacturing.
3. Weigh, Mix and Mill materials where applicable during course of manufacture all
these in accordance with GMP and SOP requirement.
4. Maintain high level of personnel hygiene.
5. Operate machinery in accordance with SOP.
6. Enable production manager have better over -view.
7. Filling of monthly working hour sheets for liquid unit as appropriate.
8. Ensure a clean working area at all time to meet GMP and in – house standard.
9. Receive raw materials from the warehouse in accordance with written guidelines.
10. Any other work related duties as may be assigned from time to time by the production
manager.
7. Marketing Officer Aug 1995 – Dec
1996

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Inter-Regional Ventures Ltd. Lagos
8. Science Teacher (NYSC) 1994 - 1995
Government Secondary
School Ngasky. Kebbi
State
9. Industrial Attachee 1990 - 1991
Super – Link Pharmacy Ltd. Lagos
10. Industrial Attachee 1989 (2 – months)
(a) Federal Ministry of Health
Yellow Fever Vaccine Production Laboratory
Yaba. Lagos.
(b) Federal Ministry of Health 1989 (2 – months)
Anti-Rabies Vaccine Production Laboratories
Yaba, Lagos

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COURSES ATTENDED
S/N Date Course/Provider
1 March 1997 Six months induction training
Roche Nigeria Limited
2 June 22, 2000 Product Quality Improvement
Pharmaceutical Manufacturers Group of the MAN
3 May 28-Jun 1, 2001 Quality Control / Assurance in Pharmaceutical Industry
Industrial Training Fund
4 Nov 23-24, 2001 Strategic Quality Management (TQM/ISO 9000) series
Alpha – Gold Nig Ltd
5 Sep. 20, 2002 Enhancement of Quality Excellence
Pharmaceutical Manufacturers Group of the MAN
6 Oct 17-19, 2002 Quality Operations , Practices and Procedures
Alpha – Gold Nig Ltd
7 Nov 11-14, 2002 Improving Product Quality for Export–ISO 9000
African Management Service ( AMSCO ) and
African Project Development Facility ( APDF )
8 Jun 11-14, 2003 Training Workshop on Stability Data Analysis
LACTO – MEDALS Ltd. Lagos
9 Aug 4-5, 2003 cGMP Trends: Building Capacity for Proactive Compliance
Fine Spectra Consult and NAFDAC
10 Sep/Oct, 2004 MS-Word, MS-Excel, MS-PowerPoint, MS-Outlook, MS-Access
Aptech Worldwide. Lagos
11 Nov 29-30, 2004 Achieving Six Sigma Performance
Phillips Consulting. Lagos
12 Mar 16-19,2005 Pre – Admission Training Workshop on Food, Drugs,
Cosmetics, Medical Devices, Water, Environment and Petroleum
Institute of Public Analysts of Nigeria
13 Apr 18-22, 2005 ISO 9000:2000 Introductory Course
Standard Organization of Nigeria
14 Aug 19-20, 2005 Challenges of current GMP for the World-Class Manufacturer
Fine Spectra Consult
15 Mar 29-30, 2006 Quality Assurance in Analysis
16 Apr 3-7, 2006 ISO 9000:2000 Lead Auditors Course
17 May 25-26, 2006 Implementing a successful validation program
Fine Spectra Consult
18 Nov 28, 2006 Technical Seminar on Facility Validation/GMP Documentation
Pharmaceutical Manufacturers Group of MAN/Doshi Consultants ( P ) Ltd.
India
19 Dec 6-7, 2006 Fundamentals + Essentials of Validation Pharmaceutical Water Systems
Rodot Nig Ltd and Globepharm Consulting USA

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20 May 2-3, 2007 Water
21 Sep 16 -20, 2007 ISO 14001: 2004 EMS Implementation Course
22 Nov 27-28, 2007 International Training on GMP
PMG – MAN
23 Dec 8-12, 2008 ISO 14001:2004 EMS Audit Course
24 Feb 5-9, 2009 Analytical Method Validation
Alpha Gold
25 Feb 25-26, 2009 ISO 9001:2008 Lead Auditors Course ( Revalidation )
26 Aug 17-21, 2009 ISO 14001:2004 EMS Advance Auditors Course
27 Sep 5, 2008 Effective HSE Management
Multiple Development Services Ltd.
28 Nov 10-11, 2009 Quality Assurance in Laboratory Management
29 Jan 14, Feb 4, 2010 Validation of Cleaning Procedures
Alpha-Gold Ltd
30 May 8-12, 2010 cGMP Practice Training
Pharma Energie, France
31 Jun 2-4, 2010 Workshop on Basic Management Process
Tom Associates
32 Sep 17-18, 2010 Workshop on Team Building and Bonding
Mbk Training and Consulting
33 Nov 8-9, 2010 Health and Safety: What role for microbes and the analyst
34 May 23, 2011 Inspection of Quality Control Laboratory
swiss pharma nig. Ltd
35 May 26, 2011 Good Documentation and Quality Management Principles
36 Aug 30, 2011 cGMP Documentation
The Ambassadors Consultants
37 Sep 15, 2011 cGMP Documentation – Air Handling System HVAC
38 Sep 27 – 29, 2011 Problem Solving & Decision Making For Executives
Lagos Business School (LBS)
39 Nov 2011 Audit/Supervision of production process for Arenax Dry Syrup, Arenax Forte
Tablet AND Ocefix Dry Syrup
VapiCare Pharma Pvt. India
40 Dec 07, 2011 Self Inspection
41 Dec 13, 2011 RABQSA-AU : Management System Auditing
MSA Certification Co., Ltd.

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42 Dec 16, 2011 RABQSA-TL: Leading Quality Management System Audit Team
43 Dec 20, 2011 RABQSA-EM: Auditing Environmental Management System
44 Feb 13, 2012 Handling of OOS Results
45 Mar 16, 2012 CAPA
46 Apr 14, 20 & 21,
2012
Effective Management of the Analytical Laboratory
Fine Spectra Consult Limited
47 Jun 22, 2012 Auditing Principles for GMP Audit
48 Jun 22, 2012 Understanding Worldwide Regulatory Requirement
49 Jun 29, 2012 Auditing a Documentation System
50 Jun 29, 2012 Auditing a Deviation System
51 Jul 18-20, 2012 Operations Management
Tom Associates
52 Sep 14, 2012 Change Management
53 Sep 28, 2012 Sampling and Sample Management
54 Dec 11, 2012 Managing Non-Conformance/Deviation Investigations
CEO of ONYEXXPHARMA LLC, USA, (Dr. O. Chukwumerije)
55 Dec 12, 2012 Implementing an Effective Corrective Action/Preventive Action Program
56 Dec 13, 2012 Handling Laboratory OOS and Failure Investigations
57 Mar 25, 2013 Quality Risk Management
58 May, 2013 2nd
Line TB Medicines Manufacturers Workshop
USAID – PQM, USP, USA, Accra Ghana
59 Oct 29 – 30, 2013 Trainers Development Workshop
Industrial Training Fund (Ikeja Area Office)
60 Nov 30 – Dec 01,
2013
PMBOK5 Edition: PMP Training
Simplilearn Nigeria Limited
61 Feb 19, 2014 Quality By Design (Webinar)
ASQ (Mark J. Anderson)
62 Mar 29, 2014 Audit of Active Pharmaceutical Ingredient Manufacturer
Vital Healthcare Pharma Ltd., India
63 Mar 30, 2014 Audit of Active Pharmaceutical Ingredient Manufacturer
Vital Laboratories Pharma Ltd., India

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64 Mar 31 – Apr 2, 2014 Follow-up Audit/CAPA verification
Vapicare Pharma Pvt. Ltd., India
65 Apr 03, 2014 Vendor Audit
Pradipkumar Pharma Pvt India (Warehouse)
66 Apr 9, 2014 Environmental Mapping – Temperature Mapping Protocols
Vaisala
67 May 16, 2014 Best Practices for implementing a global change management
swiss pharma nigeria Limited (webinar)
68 Jun 13, 2014 Introduction to PS9004/PS9000:2011
69 Feb 13, 2015 Annual Product Quality Review
70 Apr 14 – 15, 2015 Dossier Preparation for Prequalification of Misoprostol tablet
Concept Foundation, Geneva. Switzerland
71 May 15, 2015 Handling Out Of Specification results
.
REFERENCE
To be provided on request

harold_cv052015

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