Senior Manager

Job Description

• 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.

Work Experience

12-15 years

Education

Competencies