Expert Details

Expert in Pharmaceutical Quality Assurance

Expert ID: 723891 India

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He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA / MHRA / ANVISA / WHO / Health Canada).

He supported regulatory teams in review and filing of various dossiers in US/EUROPE/CANADA/MCC/BRAZIL and various regulatory agencies across the globe. Implemented high standard of quality in all areas of ANDA submissions for Tablets / Capsules /Dry Syrups/Oral solutions. He assisted in preparation of supplements, annual reports and amendments. Review of Stability data/Trends/Impurity profiles. Successfully handled various regulatory inspections. Thorough knowledge in change control process.

He is well versed with the preparation, review & execution of Validation Master Plan, qualification / validation activities related to equipment / machinery, utility systems [steam, compressed air, HVAC system, water system etc] process, cleaning & facility. Managing written procedures for production and process control designed to assure that the products have the identity, strength, quality, and purity they purport or are represented to possess. Established control procedures to monitor the output and validate the performance of those manufacturing processes responsible for causing variability in the characteristics of in-process material and the product. Initiated, implemented and controlled written manufacturing specifications and processing procedures to assure that the device conforms to its original design or any approved changes in that design.

He was a qualified auditor by Pfizer for auditing contract manufacturers and suppliers during his tenure at Parke Davis (Pfizer. Audits laboratory data for compliance with methods and standard operating procedures and report findings .Audits sample result tables and analytical reports for completeness and accurate representation of the data and report findings .Conducts project specific inspections of laboratory procedures to evaluate compliance with analytical methods and standard operating procedures and report findings. Client and inspector interaction. Conducts general facility inspections as assigned. Conducts audits of vendors and subcontractors as assigned. Evaluates audit and inspection findings and consults with supervisor regarding appropriate course of action and reporting requirements .Identifies issues which may require follow-up inspection and consult with supervisor for scheduling follow-up inspection. Validated contract manufacturers and material suppliers.

Built quality systems, rewrote SOPs, designed and implemented new batch record system, directed validation group, and developed and implemented training program. Taken active role in simplifying the procedures keeping the regulatory compliance. Introduced statistical tools, Training information management system, Quality Management System modules(software), Document management systems (software),etc. Having core QA expertise. Involved in designing Greenfield projects for formulations.

Education

Year Degree Subject Institution
Year: 1988 Degree: Masters in Science (M.Sc) Subject: Chemistry Institution: Andhra University
Year: 1985 Degree: B.Sc Subject: Math, Physics, Chemistry Institution: The Hindu College
Year: Degree: Certificate course in Statistical Quality Control Subject: Statistical process controls Institution:

Work History

Years Employer Title Department Responsibilities
Years: 2003 to Present Employer: Undisclosed Title: Senior Manager Department: Responsibilities: He is responsible for Overall administration of Quality Assurance department.
Responsible for overall Quality compliance, validations, manufacturing compliance, analytical assurance documentation;
Oversee proper facilities are made available for production of existing and new products and to ensure proper Technology Transfer from formulation Research Division to Production;
To ensure compliance of the validation protocols of facilities, equipment and process, cleaning, analytical methods and utilities;
Managing overall QA documentation activities;
Review of stability data;
Responsible for release/rejection of In-process materials and finished products;
Managing Vendor approval program and vendor audits;
Review and release of Batch Processing and Packaging Records;
Coordinating change controls, Deviations and OOS;
Conducting failure investigations and monitoring CAPA;
Investigating complaint handling;
Reporting quality problems to higher management;
Handling customer audits, External supplier audits and regulatory inspections;
Supporting regulatory affairs for registration of products, review of documentation to comply with license and regulatory requirements;
Liaising with customers with regard to any quality or technical queries and contract issues;
Responsible for implementation of new systems to improve existing operations;
Review, authorization and ensuring the compliance of Technical agreements;
Review, authorization and ensuring the compliance of documents for applying the variations to MHRA
Years: 2002 to 2003 Employer: Emcure Pharmaceuticals Limited, Title: Manager Department: Responsibilities: His responsibilities are
Assisting project coordinator in reviewing and finalization of specifications for process, QC and engineering equipment.
Preparation and review of various concept documents of the project.
Led the validation team in carrying out Equipment Qualification and Validations.
Designed and developed specifications for the equipment being procured. Reviewed User Requirement Specifications (URS).
Reviewed and approved DQ/IQ/OQ protocols of equipment and facilities.
Responsible for total Quality Assurance operations
Prepared and Reviewed cGMP documents as per regulatory requirements.
Developed various quality system Standard Operating Procedures and training, Disposition of Raw materials, packing materials and finished products.
Member in Quality Review Meeting. Responsible for setting specifications and parameters for Active Raw Materials and Finished Products.
Years: 1994 to 2002 Employer: Parke Davis India Limited (Now Pfizer,) Title: Senior Officer Department: Responsibilities: His responsibilities were
To carryout Qualification of new equipment and existing equipment
Preparation of Validation Master Plan, Preparation and execution of Process validation & cleaning validation protocols as per the schedule.
Preparation of Annual Product reviews of all in-house and third party products.
Conducting internal audits, contract manufacturer audits and supplier audits, preparation of reports and follow up of compliance action plan.
Investigating and documenting of Process Deviations
Responsible for change controls and change implementations.
Conducting cross-functional Investigations, laboratory investigations in case of failures, preparation of reports and implementation of corrective action plan.
Review of system and operational SOPs.
Years: 1994 to 1996 Employer: PHARMANALYSTS Title: CHEMIST Department: Responsibilities: Analysis of Raw materials, In-process materials and Finished Products by chemical, instrumental and microbiological techniques.batches

Additional Experience

Training / Seminars
He has developed various in-house training modules on GMP and conducted training in all the organizations he has worked for. He has also conducted training in pharmaceutical associations/congress in the country.
Vendor Selection
He was a trained/qualified corporate quality auditor from a Major MNC. He has audited various vendors of API's, Recipients, Packaging material vendors and has developed a vendor rating system. He has also been involved in identifying potential pharmaceutical manufacturers for outsourcing activities.

Language Skills

Language Proficiency
English

Fields of Expertise

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