Job Role Summary : QMS Documentation and review, investigations, IPQA activities, self inspection
Job Profile
- Review & approval of Quality system related documents like change controls, deviations, market complaint, OOS, IPOOS, OOT & CAPA.
- To monitor and coordinate IPQA activities in manufacturing and packing area.
- Review and approval of master documents like SOPs, protocol and reports, specifications, standard test procedures, batch manufacturing record, batch packing records OPML etc.
- Review and approval of quality risk management.
- Review and approval of APQR and implementation of recommendations from APQR.
- Review and approval of hold time study documents, validation and qualification documents.
- Approval of various documents in SAP system.
- Performing self-inspection, audit of contract testing laboratory/third party vendor audit/vendor audit and review of related documentation.
- Investigation of quality matrices like deviations, out of specification results, out of trend results, market complaints, batch failures etc.
- Handling the regulatory audits/Inspections and ensuring the responses & compliances.
Job Requirements
- 12 - 15 years' experience in Pharma Quality operations
- Familiar with cGMP requirements and documentation - APQR, Incident Investigations
- Self Inspection, Facing regulatory audits
Work / Job Experience : 12-15 Years Type of Experience : regulated pharma QA experience
Academic Qualifications
Graduation in Pharmacy
Job Post Link : https://careers.lupin.com/job/IRF-Aurangabad-Senior-Manager-MH/(phone hidden)/
- Full Time
- India | Maharashtra | Aurangabad
- Posted 1 hour ago
Website Linkedin Lupin Limited To apply for this job please visit tinyurl.com.