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Sun Pharmaceutical Industries Limited is taking this opportunity to balance employment and the medications to the world. We are hereby inviting candidates who are interested to join India's No. 1 company in Pharmaceutical sector.
Post : Senior Executive (Analytical Research - QA)
Job Description
• Developing procedures / system and for assuring compliance of the R&D function.
• Ensure the Compliant of analytical method validation/verification of Excipient, intermediates, Drug substance, Drug Product and technology transfers to the manufacturer organisation.
• To draft, review guidelines /SOPs/Protocols/Reports associated with the product development.
• To review and assess data based on Analytical QBD based approach. To ensure analytical development data supports to robust test method and suitable to entire product lifecycle.
• To review and approve of QMS like change control, deviation, events, OOC, CAPA for cGxP compliance and centralised QA oversight for Analytical Development Department.
• To review and approve of Plant Trouble Shooting Report and Analytical technical report to support Agency query and/or site investigation.
• Expertise in Quality Risk Management Method & Tools (Like Failure Mode Effects Analysis (FMEA), Fault Tree Analysis (FTA), Heatmap, Fishbone etc).
• To review and approve Standard Test Procedure and specification.
• To have understanding on the pharmacopeial compliance
• Review and approve the extractable and leachable study reports.
Candidate Profile
M. Sc/ M. Pharm
Understanding of CGMP To understand and interpretation of data of sophisticated analytical instruments like HPLC, GC, IC, SEM, TEM, Auto-titrator, UV spectrophotometer, FTIR, Particle size analyzer, ICP-MS, LC-MS, GC-MS, HRMS, XRD, DSC, Dissolution, Viscometer, Rehometer etc.
Communication skill : Prioritization according business requirement.
Additional Information
Experience : 6-10 years
Qualification : M.Sc / M.Pharm
Location : Vadodara
Job Grade : G11B
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : AVP (RnD Quality Head)
End Date : 30th September, 2024
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