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Manager - Quality Assurance (Biotech)

Manager - Quality Assurance (Biotech)

Lupin

12 - 20 years

15 - 17 Lacs

Pune

Posted:4 hours ago| Platform:

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Skills Required

Equipment qualification Biotechnology HVAC Manager Quality Assurance Risk assessment QMS thermal Vendor Monitoring

Work Mode

Work from Office

Job Type

Full Time

Job Description

Knowledge of equipment qualification, facility qualification, CSV, QMS

Review of the Equipment Qualification Protocols and Final reports and Monitoring of the Equipment Qualification like IQ, OQ and PQ. Review of Qualification documents for IQ, OQ and PQ done by the Vendor/Third party related to Instrument integrated with equipment

Experience in handling of QMS related activities: Change control, Deviation, CAPA

Experience in drafting of technical reports, Quality risk assessment, water trend report,
Annual equipment performance review report and perform gap assessment against regulatory guideline.

Review of periodic validation like, steam sterilizer validation, Thermal mapping reports, HVAC
qualification, LAFU/BSC qualification

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Lupin

Pharmaceuticals

Pune

20,000+ Employees

162 Jobs

Key People

Vinita Gupta

Chief Executive Officer
Nilesh Gupta

Managing Director
Ramesh Swaminathan

Chief Financial Officer

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Manager - Quality Assurance (Biotech)