Manager- CMO
SUN PHARMA
Date: 3 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
Position: Manager 2 - CMO
Department: Corporate Quality
Location: Mumbai/ Baroda
Reporting Manager Title: DGM- CMO
Job Summary
Department: Corporate Quality
Location: Mumbai/ Baroda
Reporting Manager Title: DGM- 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.
- To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that all SUN affiliates, Suppliers and SUN sites / Operational Units to achieve, maintain and improve the adequate level of compliance, through “Independent auditing and Follow-up”.
- Monitor and oversee activities carried out at CMO sites to ensure compliance with SUN Pharma standards and current regulatory guidance.
- Regular oversight visits of the CMO sites for review of process & practices and accordingly prepare visit reports.
- Act as the single point of contact (SPOC) for coordinating with the SUN site, commercial team, corporate quality audit, and the CMO site on matters related to product manufacturing, 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 FP COA/COC for batch release. And release of batches in SAP HANA.
- 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.
- To ensure the materials used in the CMO products to be qualified as per SUN Pharma vendor management procedures.
- To participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
- To provide support during regulatory audits at CMO sites related to SUN Pharma product approvals.
- To engage in critical investigations at CMO sites, including OOS results, deviations, and complaints.
- To initiate QMS documents in the Track wise system, inform the respective CMO, and track to ensure closure of initiated QMS elements.
- To makes sure that, SUN Manufacturing Sites, Contract Manufacturing Organisations, and Affiliate Companies are prepared for Regulatory Agency Inspections e.g. through "Mock" inspections, audits and supports activities whenever required .
- To participate in the product release sites / Qualified Person sites audits to ensure that the product is being released as per the regulatory requirement.
- To maintain evidences and documents related to audit.
- To prepare Monthly report and to highlight the key area of concerns.
- To participate in the trainings to update on current / upcoming regulations.
- To follow the Corporate Quality Policies/ Global Quality Standards (GQS) and applicable Regulatory Guidelines.
- Participate and execute the project work as allotted by reporting authority.
- M.Sc./ B. Pharm / M. Pharm or equivalent.
- Total 10 years of experience
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