Good Manufacture Practices Pharmaceutical technology
MUDASSER Wali
1. MUHAMMAD MUDASSER WALI KHAN
+971504185409,+971504541079, Skype: mudasserkhan73, mmwkhan2000@gmail.com
Nattionality: Pakistan Date of Birth: 6th
April, 1973
Total Experience: 20 years UAE Experience: 3 years
PROFESSIONAL SUMMARY
Have done Masters in Zoology (specialization in microbiology) and Graduation with Chemistry with a practical work
experience of about 19 years at various levels in Quality Assurance & Quality Control departments. Have technical
experience in all the relevant fields like Quality Assurance, Quality Control, Manufacturing and Finishing.. Fulfilled the
requirement for the GMP certification of UAE Ministry of Health and got the GMP registration for Univet. Working with
ICI Pakistan Limited and The Searle Company Limited, gave opportunity to deal with the requirements for
international market. Worked as auditee for international audits. Capex give me to opportunity to implement the
Quality Management System in the plant and improvement is appreciated. Sensitivity and importance of Food
packaging for the best Quality of Food is achieved. Leadership skills are reflected in the fact that at Capex, ICI
Pakistan Limited and Searle Pakistan Limited, I lead team of highly motivated people who are directed towards the
fulfillment of their objectives.
SKILL HIGHLIGHTS
Documentation as per GMP & ISO
QMS
GMP implementation
cGMP
Media Fill trial
Trainings
OOS,CAPA
Complaint Handling
Change control, Deviation Control
Dossiers FOR Registration & Export
Export Documentation & requirements
Clean room system
GDP, GLP
Review of documents
Preparation of plan for Quality audits.
Process validation
Analytical method validations
Calibration of machines and equipments
SHE as per European guidelines
HACCP & Crises action plan
Sterility testing
Spectrophotometery
LAL testing
HPLC testing
Gas chromatography
Microbiological assay of Antibiotics
Polarimeter
Testing of drip sets
IR chromatography
Pyrogen testing
Karl Fisher apparatus
Process Validation (Media fill trial)
Flame photometery
Chromogenic Method of Edotoxin testing.
Area monitoring.
Dissolution
Freezing point apparatus
TLC
Research & Development
All Microbiological testing
Fulfill the legal requirements of monitoring
agencies & international standards.
PROFESSIONAL EXPERIENCE
International Caps,CAPEX, Jabel Ali, Dubai, United Arab Emirates.
Quality Manager
August.2014 todate
Food packaging manufacturing
United Company for Veterinary Medicines, United Arab Emirates
QA/QC Manager
Jan.2013 to July 2014
General Liquids
General Powders
Antibiotic Powders
The Searle Company Limited
QA/QC Manager
Mar. 2009 to Jan. 2013
General Liquid Section
General Antibiotic tablet section
General Tablet section
General Capsule section
Guyton Pharmaceuticals
QA/QC Manager
July 2004 –Feb. 2009
HUMAN DIVISION
General Ampoule Section Cephalosporins Section
(Capsule, Dry Powder Susp. & Dry powder Injection
2. Liquid syrup section
Quinolones Antibiotic Infusion Section
VETENARY DIVISION
Antibiotic Injection section
Liquid solution section
Powder/bolus section
General Injection Section
Medipak Ltd.
Microbiologist
Mar.1998 – June 2004
I.V. Solutions
Eye Drops
Dialysis Solutions
Ampoule Injections
General Tablets
Parenteral Vehicle
Pharmedic pvt. Ltd.
Analyst
May 1995 – Mar. 1998
Tablet Section.
Liquid Syrup Section.
EDUCATION
M.Sc (Zoology with specialization in Microbiology)
BZ University Multan, Pakistan
B.Sc. (Chemistry, Botany & Zoology)
University of the Punjab, Lahore, Pakistan
PROFESSIONAL ACHIEVEMENTS
For ICI Pakistan & The Searle Company Limited full filled the requirements of the international standards for
meeting the Exports.
Started 3 units from start including all documentation and development of products and methods.
Go through up gradation of manufacturing facility for two Mfg units including design and facility.
Developed more than 75 products.
Get the UAE Ministry of Health GMP certification for Univet.
ISO 9001-2008 certification for Capex
FSSC-22000 certification for Capex.
RESPONSIBILITIES & DUTIES
1. Ensure compliance to good manufacturing practices.
2. QMR
3. SOP management – Review, approval, system compliance.
4. Training to the subordinates on GMP, GLP & cGMP.
5. Self Inspection – review, approval, system compliance.
6. Recalls – initiation, investigation, approval, system compliance.
7. In- process quality assurance – system establishment, review, compliance.
8. Documentation – Review, approval, system compliance.
9. Master documentation – review, approval, system compliance.
10. Process / equipment / cleaning / system Validation – review, approval, system compliance.
11. Technical agreements with third parties – review and approval.
12. Calibration program – review, approval, system compliance.
13. Vendor Qualification – Audit, approval.
14. Deviation and change control management – Review, approval, system compliance.
15. Complaints – review, investigation, ensure compliance to the corrective and preventive measures.
16. Finished Product release – review, approval, system compliance.
17. Planning for quarterly, monthly and weekly.
18. Check all departments are operating according to the approved procedures and ensures the system
compliance to the approved procedures.
19. Approve or reject starting, packaging materials, intermediate, bulk, semi finished and finished
products analysis results.
20. Reviewing of quality control test procedure and other quality control procedures and records.
21. Monitoring of compliance with the requirements of approved procedures.
22. Ensures that the Monitoring of the calibration program of Machines &equipment is done.
3. 23. Ensures that the proper monitoring and the maintenance of department premises and equipments
are done properly.
24. Reviewing of relevant quality control documents as SOPs, monographs, specification, and technical
instructions.
25. Preparing and writing the relevant microbiology Quality control documents as SOPs, Protocols and
Technical instructions.
26. Microbiological monitoring of Cap to assure that no hazard for food items.
27. Monitoring the environmental monitoring program of production areas & warehouse.
28. Part of planning committee to plan the production.
29. ESH monitoring
30. Dealing with all auditors of ISO 9001-2008 from LRQA, ISO 22000-2005 from SGS.
31. Visits for customer complaints
.
COURSES & TRAINING
I have completed the following training courses and activities below:
GMP standards for UAE training by Mr. Adeel Immam, 2013.
GMP training by MOH, Lahore, Pakistan, 2012.
cGMP training by PPMA, 2006.
ISO training Courses by SGS at Medipak Limited, 2001.
COMPUTER FIELD:
Windows, Excel, Access, Word
Internet
LANGUAGE SKILLS
Fluent in English speaking/listening/writing).
Ielts done with 6.5 bands.
Urdu