1. HARPREET SINGH
Phone: +91-172-4052732; Mobile: +91-9888011171
Email: harpreetsingh1314@gmail.com
OBJECTIVE
Seeking a position to utilize my skills and abilities in the pharma industry
that offers Professional growth while being resourceful, innovative and
flexible.
EXECUTIVE SUMMARY
 Seasoned and dynamic Management Executive with a gratifying career
span of more than 19 years predominantly in the areas Equipment And
Utility and System Validation (DF), Production (API), Training and
Development (LMS), cGMP & Regulatory Compliance, Documentation,
General Administration etc.
 Significant experience of modern concepts of Quality & Value
Engineering, ensuring quality of product by using tools of ICH in Validation
(Equipment & Utility & System Qualification), etc. Facilitate preparation of
Validation/Qualification Protocols and Reports and review activities of
qualification related to Equipments, and utilities/System.
 Hands on knowledge of US FDA, MHRA(UK), EU, ANVIZA(Brazil),
PMDA(Japan),TGA(Australia),WHO GMP, regulations, successfully
conducted self-auditing of manufacturing / production areas, to ensure
GMP compliance, adequate experience in handling & reviewing
deviations, Investigations, change controls, OOS and OOTs, SOPs , VMP
(Validation Master Plan) and validation protocols and reports, OOS and
OOTs
 Consummate professional with demonstrated capability in ensuring
judicious utilization and allocation of available resources - materials,
machines and manpower, to achieve organizational targets while creating
a healthy and friendly work environment and thereby enhancing
operational efficiency.
 Computer savvy with hands on knowledge of SAP, MS-Office, Trackwise
(For change controls), Documentum Compliance Management (DCM)
(For SOP’s & STP’s), Learning Management System (LMS) (For on
line trainings).

2. CAREER MILESTONES
 Successful association with Sun Pharmaceutical Industries Limited
(erstwhile Ranbaxy Laboratories Limited) for more than 19 years.
 Executed diverse responsibilities in various departments including,
Validation (DF equipments and utilities and systems), Production
(API), Quality Assurance, Training and Development through LMS,
Regulatory Compliance Audits including US
FDA,MHRA,EU,ANVIZA,PMDA,TGA, WHO GMP and Safety Initiatives
and Documentation.
 Appreciated for outstanding performance and rewarded Excellence
Award in Ranbaxy Laboratories for improving the quality, cost savings,
inventory liquidation and reducing cycle time in 2009.
 Conducted Self-Auditing of Manufacturing / Production Areas, to ensure
GMP compliance.
 Handled and reviewed deviations, investigations, change controls,
VMP (Validation Master Plan), validation protocols, validation
reports, SOP, OOS and OOTs.
PROFESSIONAL EXPERIENCE AND ACCOMPLISHMENTS
Employed as production chemist in Feb.1997 and now as senior executive
in Sun Pharmaceutical Industries Limited (erstwhile Ranbaxy Laboratories
Limited). During this period of job I had worked in plants of sterile (Bulk
API), non sterile (Bulk API) and dosage form(OSD).
In Dosage Form (OSD) - (2012-Till date)
 I am currently handling validation activity related to all equipment and
utilities (HVAC System, Water System, Compressed Air System, Nitrogen
Air System).And performing various activities related to validation such as
URS (User Requirement Specification)
DQ (Design Qualification)
RA (Risk Assessment)
cGXP IA (Impact Assessment)
IQ (Installation Qualification)
OQ (Operational Qualification)
PQ (Performance Qualification)
FQ (Facility Qualification)
TM (Temperature Mapping)
 Successfully completed the validation activity of two projects –New
Microbiology lab and New Solvent Warehouse establishments.
 Preparation of URS for the equipment / System.
 Review of design specification offered by vendor and compares it with
URS and preparing DQ.
 Preparation of RA for the equipment / System

3.  Preparation of GXP Impact Assessment for the equipment and system to
categories as Direct, Indirect, No Impact Category.
 Preparation and Approval and Execution of validation protocol and
summary report of IQ, OQ, PQ.
 Preparation and Approval and Execution of validation protocol and
summary report of FQ and TM.
 Performing Periodic Performance Verification (PPV) of the equipments
and system as per their schedule timing to have equipment and system in
validated state of control.
 Preparing PPV calendar and PPV report matrix on yearly basis.
 To coordinate and interact with vendor, engineering department, user
department and project team for the timely completion of the validation
activities and resolve of technical issues.
 To ensure compliance of cGMP and GDP.
 Preparation of Master Validation Plan for the site
 Equipment validated-HVAC system, RLAF(Dispensing & Sampling
Booth), LAF, Water System, Compressed Air System, Area Qualification,
Capsule Filling Machine, Tablet Compression Machine, Cold Room, Sifter,
Multimill, Inverted Mode Air Jet Bottle Cleaning Machine, Domino
Printer(Ink Jet Printer), Blister Sealing Machine, Strip Sealing Machine,
Rapid Mixer Granulator, FBD, Coating Machine, Liquid Filling Machine,
Roll Compactor, Dedusting Tunnel, Sticker Labelling Machine,
Checkweigher, Dose Cup Capping Machine, Homogenizer/Colloidal Mill,
Tablet Printing Machine, Induction Sealing Machine, Filter Cleaning
Station and many more…
 I am also looking after and imparting the training through Learning
Management System (LMS) to the users of the plant. Training related to
all kind of SOP (Standard Operating Procedure) and cGMP training
 I am LTC for LMS at site, learning software supported by M/s SumTotal.
 Collate all departments Master Training Need Matrix (MTNM) for
preparing location MTNM.
 Configuring and Uploading training material and task in LMS.
 Auditing and compliance of training at site.
 Creation of Job Roles in LMS as per MTNM.
 Creating learning activities/curriculum in the system as new activity or for
revised version and categorized under SUN specific, Regulatory,
Developmental and Activity based SOP’s.
 Assigning curriculum to Job Role as per MTNM.
 Associating Job Role to the users as per MTNM.
 Training records and available in the system at all times on real time
basis.
 Monitoring Training Compliance – User Wise / Activity Wise.
 Various reports are generated such as :-
1. Completion and Compliance Reports
a) Learning activity SOP allocation to departments

4. b) Department wise Matrix Completion Reports
c) Department wise Training allocation and completion (Graph) with
detail report.
d) SOP wise department employee wise training completion.
e) Job Role wise training compliance.
f) Location wise training completed during a period
g) Location wise Manday’s summary during a period.
h) Location wise Manday’s detail report during a period.
i) Compliance reports.
2. LMS reports
a) List of Job Roles
b) List of Department / Functions
c) List of learning Activities and Topics
d) Employees Master
e) Trainer Qualification Reports
3. MTNM Reports
4. Impact Assessment Reports
5. List of Unsuccessful Attempts / Failure Attempts and many more….
 I have actively participated in getting the ISO 14001 and OSHAS for the
site.
 In Non Sterile Production (API Bulk) - (2000-2011)
 I have involved in manufacturing of cefuroxime axetil amorphous chemical
route and spray dried route. I have also handled manufacturing of
cefditoren Pivoxil Spray Dried Premix.
 I had worked in plant setup of spray drying at project stage in our
organization in the year 2005
 Review of batch production records (BPR) and in process test.
 Involved in managing operations, documentation, quality assurance,
and planning activities along with a team of 20 members.
 Manage the production planning and control activities, setting up
production targets and handling plant operations to ensure timely
completion of production targets within the defined time and cost
parameters.
 Played an important role in effective resource planning and utilization,
reducing waste for enhancing productivity and profitability.
 Involved in maintaining records as per GMP requirements, and self /
internal auditing of manufacturing / production areas to ensure GMP
compliance and quality commitments.
 Ensure adherence to various SOPs, STP & SCPs
 Prepare, Review & implement MPR.

5.  Follow up mechanism to handle and successfully close a non-
conformance.
 Initiation of Change Control and their closure
 Participated in failure investigation (Out of specification). Conducted root
cause analysis of the problem and identification of major root causes and
their remedies. Handled & reviewed deviations, change controls, OOS &
OOT.
 Qualification of HVAC (Heating ventilation and air conditioning system).
 Validation of production systems like drying validation, blending
validation.
 Responsible for installation Qualification, Operational, Qualification,
Performance Qualification of systems.
 Ensuring that the Quality Management System is maintained in
accordance with ICH Guideline.
 Drive the continuous improvements in operational qualities, setting up
controls, reviews, and implementation of corrective actions.
 People Engagements & effectives on quantity improvements projects.
 In Sterile Production (API Bulk) - (1997-1999)
 I have involved in manufacturing of sterile ceftriaxone sodium and sterile
cefatoxime, acid.
 Autoclave qualified with respect to IQ, OQ, PQ and know how to operate
the equipment, used for sterilizing filter cartridges(used for sterile
filtration),Rubber bungs, garments.
 Dry Heat Sterilizer (DHS) qualified with respect to IQ, OQ,PQ and know
how to operate the equipment. Use for sterilizing Aluminium containers,
Caps, foil and sampler etc.
 WFI (Water for injection) qualified.
 Pure steam generator qualified.
 Filter integrity testing by Bubble point method by Millipore equipment.
 Versaport-10 particle counter operated used for counting particle count on
monthly basis as per AHU classification class A, B, C, D.
 HVAC system of sterile area qualified.
 Hanging Laminar Air Flow (LAF) for class A qualified.
 Preparation and approval of validation Protocol and Reports.
 Review of batch production records and in process test.

6. PROJECTS HANDLED
1. New Microbiology Lab made operational at OSD site
Following activities carried out to related with the validation/qualification
activities :-
 Made Use Requirement Specification (URS) of the Heating Ventilation Air
Conditioning (HVAC) to be procured for the project.
 Installation Qualification (IQ) of the HVAC system performed.
 Operational Qualification (OQ) of the HVAC system performed.
 Performance Qualification (PQ) of the HVAC system performed, covering
parameters such as:-
 Air Velocity and Air Changes Per Hour
 Filter Integrity Test
 Differential Pressure Monitoring Test
 Non-Viable Particle Count Test
 Recovery of Non-Viable Particle Count Test
 Air Flow Visualization Test
 Temperature & Relative Humidity Monitoring Test
 Recovery of Temperature & Relative Humidity & Differential Pressure Test
 Viable Count Test ( Microbiological Monitoring Test)
 Made User Requirement Specification (URS) for the Facility.
 Performed Facility Qualification/Area Qualification of the facility covering
parameters such as:-
 Rooms Dimensions
 Material & Personnel flow
 Floor-MOC, Surface finish
 Doors-MOC, Size, Interlock
 Coving-MOC, Surface finish
 Ceiling-MOC, Surface finish
 Vision Panel-MOC, Size
 Drains-Air Break, Cover
 Walls-MOC, Paint colour, Paint Type, Surface finish
 Steam, Pure Steam, Compressed Air, Industrial Gasses
 Electrical & Associated-Number of lights, Illumination level, single/three
phase etc
 HVAC-Supply & Return grill number, ACPH, Temperature, Relative
Humidity, Differential Pressure, HEPA filter leak test, Particle count,
Microbiological Monitoring
 Water- Potable, Purified, Water for injection
2. New Solvent Warehouse made operational at OSD site
 In similar way as above another Project of solvent Warehouse was
handled.

7. 3. New Spray Dryer Plant- From ALFA LAVAL made operational at API
Bulk site
I have handled the project of plant set up of spray dryer
Following activities carried out during the project:-
 Installation Qualification (IQ) of the equipment performed.
 Operational Qualification (OQ) of the equipment performed.
 Performance Qualification (PQ) of the equipment performed, covering
parameters such as:-
 Taken trails with product Cefuroxime Axetil at different Inlet & Outlet
Temperature setting of the spray Dryer .
 At various RPM of the Supply blower and the Exhaust blower for the
optimisation of the speed.
 To check & verify the RPM of the Atomiser
 To check the Amorphous nature of the product, it should not be in
crystalline nature
 Spray Drying is performed to convert the crystalline form of the product
into Amorphous form.
SPECIALZED TRAINING
Gone through extensive 400hrs of training at karnataka antibiotics and
pharmaceuticals limited Bangalore in following area – Dry powder
parentrals and non parentrals and small volume parentrals and
quality control and store management. Training on fire fighting with
advanced fire fighting techniques.
ACADEMIC AND PROFESSIONAL CREDENTIALS
Bachelor of Pharmacy (B’PHARMA) from Bangalore University.
Audits Handled
US-FDA – 1998, 2000, 2003, 2007, 2008
TGA – Australia – 2000, 2004
Germany Audits – 2005, 2007
WHO – GMP Audits – 1999, 2003, 2007, 2008, 2014
PERSONAL DETAILS
Address : H.No.1314, Sector-68, Mohali (Punjab), Pin-160062, India
Date of Birth: 20th April 1972
Marital Status: Married
Blood Group: O-ve