MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Post : Sr. Manager
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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