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Manager- CMO

2 months ago

mumbai, India SUN PHARMA Full time

Position: Manager - CMO

Department: Corporate Quality

Location: Mumbai/ Baroda

Reporting Manager Title: Sr. Manager- CMO

Job Summary:

Accountable for quality oversight of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site & R&D) for US market.

Essential Job Functions:

Regular oversight visits of the CMO sites for review of process & practices and accordingly prepare visit reports. Coordinate with Sun site, commercial, 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.

Requirements and Qualifications:

M.Sc./ B. Pharm / M. Pharm or equivalent.

Industrial Experience & Knowledge:

Total 12-15 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