Designation : Senior Manager Function : Quality Assurance Functional Area : QMS, IPQA 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.