Validation & QMS Executive

1. Page 1 of 5
MANOJ KUMAR VERMA Mobile No.: +91 7508606738
Email: manojkverma2003@gmail.com
Overall 13 plus Years of experience including on-site Projects in India and Overseas and
Quality Assurance (QA) of state of the art GMP facilities of Sterile Dosage Forms of Biotech and
Biotherapeutics companies; have faced audits - WHO-Geneva qualification inspection for rec.
Hepatitis B Vaccine, Indian FDA qualification inspection for inactivated viral vaccine against Foot-and-
mouth (FMD) disease, ISO 13485 of British Standards Institute for Medical Devices, CDSCO and
FDA joint Inspection for Cord Blood Banking. CDSCO and Indian FDA joint Inspection for
Erythropoietin (EPO) and Insulin & its analogues (Glargine and Lispro). Applied knowledge of
Quality Systems (QMS), Commissioning & Qualification and Validation. Knowledge of
Regulatory affairs (RA) & GMP regulations as per ICH Q7, USFDA21 CFR part 210 & part 211 &
WHO GMP. Knowledge of General Industry Standards such as ASME BPE & ISPE Baseline
Guides.
Presently, associated with Hyde E & C India Pvt. Ltd., A Biopharma and Pharma
Consulting company, Hyderabad. Other renowned companies worked with are Panacea Ltd.,
Punjab, Lupin Ltd. (Biotech Division), Pune, Maharashtra and Wockhardt Ltd., Waluj,
Aurangabad, Maharashtra.
CAREER OBJECTIVE:
I want to provide my best services to the organization I am associated with by virtue of my knowledge &
experience and to excel in my field of work by consistent efforts.
ACADEMIC PROFILE:
Degree/Level Board/University Division; Marks in
%
Year of
Passing
MBA, Total Quality
Management
Sikkim Manipal University (Distance
Learning Course)
First Division ; 65% 2014
M.Sc. Microbiology
Gurukula Kangri University,
Haridwar, UA, India
First Division ; 64.6 2001
 General Certificate Course on Intellectual Property (IP) by Distance learning from WIPO.
POTENTIAL STRENGHTS:
 Quick learner and easy adaptability to new methods and systems.
 Excellent cross-functional team working and influencing skills.
 Capable of leading the team by example to complete the assigned responsibilities within the given
timelines.
 Capable of making good decisions and able to resolve problems/issues pertaining to People,
Processor systems without compromising the Quality.
 Possess Good communication, presentation and training skills.

2. Page 2 of 5
PROFESSIONAL ACHIEVEMENTS:
 On-site Projects in India and Overseas : Commissioning and Qualification of Pharmaceutical
Systems. Qualification of Steam Sterilizer in Shantha Biotechnics Ltd., (a Sanofi company),
Hyderabad, India.
 Effective implementation of Quality Management Systems in new Foot and mouth disease Vaccine
plant of B.V. Biologicals, A Division of VHPL, India.
 Qualifications, Validations, and effective Implementation of Quality Systems in new Stem Cell
Therapy Plant of Regenerative Medical Service, RegrowR
, Lonavla, Pune and Headed QA Team to
qualify audits - CDSCO and FDA joint Inspection for Cord Blood Banking and BSI ISO 13485 for
Medical Devices.
 Active participant in successful Technology transfer (TT) of Hepatitis-B r-DNA Vaccine product from
Heber Unit of Cuba to Panacea Biotec Limited Unit, Lalru, Punjab, India.
 Received the Best Presentation award on “Clean room in Pharmaceutical Industry” at Wockhardt
Limited, Aurangabad, Maharashtra, India.
PROFESSIONAL EXPERIENCE:
 Hyde E & C India Pvt. Ltd., Hyderabad, A.P., India [27 Oct.’ 2014 to Till Date]
Associated with Hyde E & C India Pvt. Ltd., A US based Biopharma and Pharma Consulting company;
designated as Asst. Manager, Validation. The company is a global design and consulting organization
providing process system design, commissioning and validation, FDA compliance, and state-of-the-art
cleaning technologies to pharmaceutical, bioprocess and other regulated process industries for two
decades.
Job Profile:
1. To organize, manage and execute Commissioning and Qualification of equipment and systems.
2. To manage important Quality Management System elements – Deviation, CAPA and Change
Control.
On-site Projects in India and Overseas during association with Hyde:
1. Shantha Biotechnics Ltd., (a Sanofi company), Hyderabad, India (02 months): Protocol Preparation
and Commissioning & Qualification (C & Q) of Process Equipment and Vessels.
2. Pfizer Ltd. (formerly Hospira Ltd.) (11 months), Visakhapatnam, India: Protocol Preparation and
Commissioning & Qualification (C & Q) of Process Systems and Vessels of Injectable Facilities.
3. Trust Pharma Ltd. (formerly Farmapex Ltd.), Ho Chi Minh, Vietnam (Jan. 25, 2106 to Till Date):
Protocol Preparation and Commissioning & Qualification (C & Q) of Facility and Utility & Process
Systems of Pharmaceuticals and Antibiotics Facilities.
 Wockhardt Limited [26 Sep.’ 2011 to 08 August’ 2014 (02 years & 10 months)]
Associated with Wockhardt Ltd., Biotech Park, Waluj, Aurangabad, Maharashtra; designated as Sr.
Executive, QA. The company is engaged in manufacture of Insulin & its analogues (Glargine and Lispro)
and Erythropoietin (EPO) by r-DNA technology.

3. Page 3 of 5
Job Profile:
1. To manage main elements of QMS – OOS, Deviation, CAPA and Change control management.
2. Organizing and coordinating to conduct Self-inspection in GMP Facility.
3. Organizing and coordinating to conduct GMP training of personnel.
4. To review equipment qualification and system validation documents.
 Lupin Biotech [27 Feb.’ 2010 – 24 Sep.’ 2011 (01year & 07 months)]
Associated with Lupin Biotech Ltd., Pune, Maharashtra, designated as Executive, QA. Lupin is a
leading transnational Pharma company. It exports its Products in more than 70 Countries. At its present
site the company has got Test License for Biotherapeutics Products - GCSF, PEG-GCSF, interferon-
alpha-2b, Rituximab, Enbrel, IL-11, PTH, PEG-Interferon. Company shall start its commercial batches in
its state-of-the-art GMP facility.
Job Profile:
1. Coordination in Clean room qualification as per ISO 14644 guidelines - Review of Protocol; supervise
the activity for its execution as per Protocol and review of Report.
2. Coordination in System / Equipment (HVAC, Steam Sterilizer, Ultra low temperature freezer, Water
system) Validation/Qualification and Review of Protocols including URS, DQ, IQ, OQ, PQ).
3. Preparation and review of Quality System SOPs of Quality Assurance such as SOP on SOPs,
Organization of Documentation, Deviation Management, CAPA Management, Change control
Management, Self Inspection as per cGMP regulations.
4. Qualification of Vendors / Suppliers / External Test Laboratories.
5. To coordinate in training of personnel working in GMP Facility.
6. Review of Protocol & Reports of Stability of Drug substances and Drug products.
7. Coordination with Regulatory affairs (RA) department to fulfill their documentation requirement from
QA.
 Regenerative Medical Services Pvt. Ltd. [02 Sep.’ 2009 – 18 Feb.’ 2010 (06 months)]
Associated with Regenerative Medical Services Pvt. Ltd., Lonavla, Pune, Maharashtra, India;
designated as Manager, QA. The company was engaged in Cord Blood preservation and catering of
Sterile and Processed Autologous Bone cell and Autologous Cartilage cell for Implantation. These are
Technology Transfer Products from Sewon Cellontech, South Korea.
Job Profile:
1. To organize, coordinate and supervise for implementation and Maintenance of Quality system as per
ISO 13485:2003 requirements.
2. Implementation and maintenance of Quality systems as per current Good Manufacturing Practices
(cGMP).
3. Risk Management as per ISO 14971 requirements.

4. Page 4 of 5
 B.V. Biologicals, A Division of VHPL [01 Mar’ 2006 – 31 Aug’ 2009 (03 Years and 05 months)]
Associated with M/s B.V. Biologicals, A Division of Venkateshwara Hatcheries Pvt. Ltd., Pune,
Maharashtra, India; designated as the Manager, QA Department. The company was engaged in FMD
Vaccine.
Job Profile:
1. Review of Tier I documents (Quality Manual, Site Master File, Master Formula, Master Validation
Plan), Tier II documents (Protocols, SOPs, Work Instructions) Tier III documents (BMR, BPR,
ATDS).
2. Qualification of Vendors / Suppliers / External Test Laboratories.
3. To recommend release of Batch upon reviewing COAs and documents generated during
Manufacturing.
 Panacea Biotec Ltd. [03 Jun’ 2002 – 17 Feb.’ 2006 (03 yrs. and 08 m)]
Associated with M/s Panacea Biotec Ltd. Lalru, Punjab; designated as Senior Scientific Officer in
Quality Assurance (QA) Department of Vaccine manufacturing Unit (a WHO-Geneva pre-qualified).
The company was engaged in Hepatitis B vaccine manufacturing r-DNA technology.
Job Profile:
1. Drafting, preparing and review of Standard operating procedures (SOPs) pertaining to Quality
Assurance Department.
2. To review completed ‘BMR’ submitted by Production Department and
completed ‘Analytical File’ submitted by Quality Control Department for its completeness as per
SOP.
3. To Prepare Product Summary File of reviewed Active Raw Material (Drug substance) and
Finished Product batches as per WHO TRS format.
4. Reviewing Batch related reports (BPR, QC Analytical Report, Utility Report & Environmental
Monitoring Report) and COA (Certificate of Assurance) and recommending for release of finished
product.
 TEACHING EXPERIENCE:
 Associated with IPER, Pune, Maharashtra, for Two years as a Guest Lecturer to teach topics
on GMP.
 COMPUTER SKILLS:
 Computer savvy – MS office; SAP and good typing speed on computer.
 PERSONAL PROFILE:
Date of Birth : June 12, 1978
Marital Status : Married
Nationality : Indian
Passport No. : M 7711007
Correspondence Address: H. No. 2009/36; Sector 32 C; Chandigarh

5. Page 5 of 5
PIN Code: 160031, INDIA
Permanent Address : H. No. 2009/36; Sector 32 C; Chandigarh
PIN Code: 160031, INDIA
 Professional References:
Mr. Vasan Thatai, DGM, QA Department, Wockhardt Limited, Biotech Park, Aurangabad,
Maharasthtra, India. Cell No. +91 70381 24680 ; nasav1@rediffmail.com
Dr. Varsha Govardhan, DGM, QA Department, B.V. Biological, A Division of VHPL, Pune,
Maharasthtra, India. Cell No. +91 95270 67300 ; vgovardhan@hotmail.com ; varshag@vitasci.com ;
www.vitasci.com
Place :
Date : (Manoj Kumar Verma)