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Manager / Sr.Manager CMO Quality

3 months ago

mumbai, India SUN PHARMA Full time
Job Summary
• Accountable for quality oversight of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site & R&D) for US market.
Roles & Responsibilities :
• Regular oversight visits of the CMO sites for review of process & practices and accordingly prepare visit reports.
• Coordinate with Sun site, commeracial, corporate quality audit & the CMO site as SPOC for activities related to product manufacturing and release and other technical issues.
• To author and review quality agreements between Sun Pharma & CMO site. Also, ensure qualified and approved external service providers are used.
• To ensure presence and participation during manufacturing for process validation batches to ensure that the manufacturing process as per the approved BMR is followed.
• To witness testing of process validation batches including hold time studies and in-process testing are conducted as per the approved specification, test procedures & protocols.
• Review of quality system documents, facility & equipment’s, manufacturing & packing controls, labelling & laboratory controls at the CMO site at regular intervals.
• Cause based /routine visits to CMO sites (with reference to Market Complaints/Recalls/CAPA implementation and effectiveness check)
• Review of batch manufacturing & packaging records, analytical reports and COA/COC for batch release. And release of batches in SAP.
• Review of stability data, process validation report, analytical method validation report, specification/STP of FP, API COA, primary packing material COAs, approved vendor of RM/PM, APQR etc.
To review quality system documents such as change controls, deviations, CAPA, OOS/OOT, product quality complaints, Recalls etc.
• Prepare & review SOP’s as per Sun Pharma quality standards.
• Prepare approved vendor list for raw materials and primary packaging materials for the product to be manufactured at the CMO site.
• To prepare annual risk assessment of the CMO sites.
Basic Qualification : M.Sc./ B. Pharm / M. Pharm or equivalent
Industrial Experience & Knowledge:
• Total 15-18 years of experience in Quality Control, Quality Assurance, Quality and compliance, in sterile formulations manufacturing.
• Knowledge of GMP’s in both domestic and international regulatory environments. In-depth knowledge of FDA guidance’s such as ICH is must.
• Strong organizational, interpersonal and communication skills.
• Ability to work effectively in multicultural matrix organization.