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Tuesday, March 27, 2012

Head QA (API) - Vapi

Job Description
• Ensuring high standard of quality in all areas of manufacturing of API plant as per USFDA and other regulatory agencies.

• Exposure of Handling various audits for regulated market like : WHO, USFDA, EDQM etc.

• Exposure of handling various Customer audit.

• Supporting manufacturing functions through implementation of current Good Manufacturing Practices (cGMP) and Quality Assurance Systems.

• Preparation of Master validation plan, Site Master File, Standard Operating Procedures (SOPs), Specifications, Quality System Procedures, Quality System Manual.

• Training of personnel on various aspects of current Good Manufacturing Practices (cGMP), Good Documentation practices (GDP) and Good Laboratory Practices (GLP).

• Product Quality Reviews, Internal Quality Audits, Implementation Quality Systems.

• Validation of Equipment’s, Process validation, Cleaning validation, AHU validation, Water system validation and Facility validation as per international regulatory guidelines.

• Preparation of registration documents as per the guidelines of USFDA, EDQM and Various Registration Documents for Product Registration.

• Handling of Market complaint, Change control, Deviation, OOS, Failure investigation and CAPA.

• Customer support and troubleshooting.

Not Disclosed by Recruiter
Pharma, Biotechnology, Clinical Research
Functional Area:
Production, Maintenance, Quality
Role Category:
Senior Management
Head/ VP/ GM-Quality Assurance/ Quality Control
quality assurance, EDQM,USFDA,CEP
Desired Candidate Profile
(UG - B.Pharma - Pharmacy, B.Sc - Chemistry) AND (PG - M.Pharma - Pharmacy, M.Sc - Chemistry)
i. Strong interpersonal relations communication and man management skills.ii. A team player and a strong ability to lead a group.iii. Conversant with cGMP norms and the USFDA rules and regulations.iv. Ability to conduct internal audits and face inspections from regulatory agencies.

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