Job Posting: Sr. Manager – CMO at Sun Pharma
Job Description
Job Summary
- Role: Sr. Manager – CMO
- Objective: Responsible for quality oversight of contract manufacturing organizations (CMOs) handling site transfer products (Sun site & R&D) for the US market.
Essential Job Functions
- Oversight Visits: Conduct regular visits to CMO sites to review processes and practices, and prepare detailed visit reports.
- Coordination: Act as the Single Point of Contact (SPOC) between Sun Pharma site, commercial, corporate quality audit teams, and the CMO site for product manufacturing, release activities, and technical issues.
- Quality Agreements: Author and review quality agreements between Sun Pharma and CMO sites, ensuring the use of qualified and approved external service providers.
- Manufacturing Participation: Ensure presence and active participation during manufacturing for process validation batches to confirm adherence to the approved Batch Manufacturing Record (BMR).
- Testing Supervision: Witness and oversee testing of process validation batches, including hold time studies and in-process testing, in compliance with approved specifications, test procedures, and protocols.
- Document Review: Regularly review quality system documents, facilities, equipment, manufacturing and packing controls, labeling, and laboratory controls at CMO sites.
- Cause-Based Visits: Conduct routine and cause-based visits to CMO sites to address market complaints, recalls, Corrective and Preventive Actions (CAPA) implementation, and effectiveness checks.
- Batch Review: Review batch manufacturing and packaging records, analytical reports, Certificates of Analysis (COA), and Certificates of Conformance (COC) for batch release, and manage batch release in SAP.
- Data Review: Review stability data, process validation reports, analytical method validation reports, specifications, Standard Test Procedures (STP) for finished products, API COA, primary packing material COAs, and approved vendors for raw materials/packaging materials.
- Quality System Documents: Review change controls, deviations, CAPA, Out of Specification (OOS)/Out of Trend (OOT) results, product quality complaints, and recalls.
- SOPs Preparation: Prepare and review Standard Operating Procedures (SOPs) according to Sun Pharma quality standards.
- Vendor List Preparation: Prepare an approved vendor list for raw materials and primary packaging materials for products manufactured at CMO sites.
- Risk Assessment: Conduct annual risk assessments of CMO sites.
Candidate Profile
- Educational Qualification: M.Sc./B. Pharm/M. Pharm or equivalent.
- Experience: 15-18 years in Quality Control, Quality Assurance, and compliance within sterile formulations manufacturing.
- Regulatory Knowledge: Comprehensive knowledge of Good Manufacturing Practices (GMPs) in domestic and international regulatory environments. Proficiency in FDA guidelines and ICH standards is essential.
- Skills: Strong organizational, interpersonal, and communication skills. Ability to work effectively in a multicultural matrix organization.
Additional Information
- Experience: 15-18 years
- Qualification: M.Sc./B. Pharm/M. Pharm
- Location: Mumbai / Baroda
- Industry Type: Pharma/Healthcare/Clinical Research
- Department: Corporate Quality
- End Date: 20th July 2024
Join Sun Pharma, a leader in pharmaceutical innovation and quality, and contribute to our mission of improving healthcare globally. Apply now!
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