GMP in Drug Stability, Drug Development and cGMP, FDA, and ICH Quality and Compliance Expert

Technical Consultant #2486

Sterile, solid orals, liquid orals, dermal products; various dosage forms.
Managing strategic and operational performance of Quality Department providing:
Development and implementation,
Standardized quality system processes,
Review of standards for quality control,
Regulatory compliance,
Quality control systems and procedures (GLP).
Pharmaceutical industry (Formulations).
Quality Management System (QMS); Complaints, recalls, deviations, change control, OOS, OOT, CAPA, self-inspections, and annual product review.
Audits and compliance (Internal and external).
Third party audits Supplier and subcontractor audits.
Production management.
Validations (process; area; equipment; cleaning).
Policies and procedures.
Quality management and continuous improvement.
On site implementation of LIMS and LES; Learning Management System for employee training, Minitab software for APQRs.
ANDA Filings.
New projects; expansions.
Implementation of QRM and data reliability procedures.

Independent Contractor, Present

As lead consultant and deviation coach in association with Proclinical U.K. for the Pfizer Chennai (IKKT) site for training, development of the employees and investigations and closure of the QMS (deviations, change controls, events, quality assurance reports, field alert reports, etc.).

IPCA Laboratories Limited, Mumbai, India, Vice President Corporate Quality Assurance, 2015 - 2018

Recognized for successful audits of the formulation sites for various regulatory agencies including USFDA, WHO Geneva, Health Canada, Germany, Croatia, Colombia (INVIMA), TFDA, NAFDAC, SAMCC, Kenya, Zimbabwe, Ukraine, Russia, Belarus, Philippines, Uganda, UNICEF, etc.
Implemented corporate procedures (CSOPs) on various quality aspects for harmonization of the quality systems at all the manufacturing sites.
Reduced the rejection rate by more than 50% of the existing product complaints by streamlining the products / processes / systems through effective CAPA implementation.
Enhanced the automation there by implementation of various software in the quality system to reduce the mistakes done while manual working including Learning Management System for employee training, Minitab software for APQRs, Schedule manager software for effective scheduling of activities including stability sample management, etc.
Quality heads of the nine formulation units report to the undersigned for all the quality related matters.

Previous Positions, 1990 - 1992

Junior Production Officer in Parenteral Section (Liquid SVP)
Received approval in Small Volume Parenterals from Madhya Pradesh F.D.A., India.

Ingenus Pharmaceuticals, Mumbai, India, Head Quality Operations, 2011 - 2015

Performed quality operations and maintained them as per USFDA for its manufacturing sites in Switzerland and U.S.A. and eleven contract manufacturing partner locations in India and abroad.
Regulatory inspections.
GMP and Quality Management Systems as per quality and regulatory expectation
Implementing systems for meeting different quality standards and the relevant documents
Formulating and maintaining a Quality Risk Management system.
Main point of contact on all Quality matters, internally and externally; ensuring the development of SOPs (writing, revising and approving), Regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially.
Validations / Qualifications / Calibrations.
Quality Management System.
Training.

Glenmark Generics Limited, Mumbai, India, Deputy General Manager CQA, 2008 - 2011

Documentation related to Pharmacopoeial amendments / revisions / implementation, vendor audits and approvals, internal quality audits, quality complaints, product recalls and returns management, technology transfer
cGMP compliance,
Product release, validations, stability studies, review and approval of CQAG

T3A Pharma, Assiut, Egypt as Head Quality Assurance, 2005 - 2008

Conducted audits for WHO Geneva, EU, ISO 9001:2000, ISO 18000, ISO 14000, Romania, Syria, and Iraq, GCC and other vendors.
Quality management as per ISO, HACCP, WHO, EU and FDA.
Master documentation review and approval.
Toll manufacture audits and approval.
Supplier audits and approval.

Ranbaxy Laboratories Limited, Dewas, India, Manager Quality Assurance, 2002 - 2005

Previous Position, 1992 - 1993

Nicholas Piramal India Limited, Pithampur, India 1997 - 2002

Positions

Previous Position, 1993 - 1995

Lupin Laboratories Limited, Aurangabad, India, 1995 - 1996

Credentials

Competencies

Languages

Academic and Professional Affiliations

M.B.A. Human Resource Management, Institute of Management Studies, Devi Ahilya, India
M.S. Pharm The Department of Pharmaceutical Sciences, Sagar, India
B.S. Pharm College of Pharmacy, Indore, India