Job for Senior Manager in Quality Assurance at MSD | B.Pharm, B.Sc
Post : Sr. Manager
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Job Description
• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures of MSD and compliance with all governing regulations; review and approve changes to master batch records
• Manage routine and complex deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer
• Provide support for audits of EP/ExP by MSD and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are warranted
• Oversee repackaging activities in the ExP/EP
• Conduct routine and solves complex analytical change requests and support process modification change controls
• Stability Program management, including review of stability reports, and Annual Product Review assembly
• Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements
• Track and monitor operational and quality performance of the external manufacturer/partner an can work with supplier to develop CAPA plans
• Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine
• Support routine process validation; review and approve validation reports/tech transfer
• Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes
• Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums
Candidate Profile
• Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).
• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
Required Skills:
• Solves complex problems; takes a new perspective using existing solutions
• Works independently, receives minimal guidance
• Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME
• May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others
• Explains difficult issues and works to build alignment around a complex situation
• Accountable for a medium project with minimal resource requirements, risk and/or complexity
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
• Communicates easily in English both verbally and in writing
• Strong knowledge of External Manufacturing management, supply chain, and operations
• Lean Six Sigma / MSD Product ion Systems training
Travel:
• Ability to travel up to 25% of the time
Additional Information :
Qualification : B.Pharm, B.Sc
Location : APAC-IN-MH-Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : QA
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