Senior Specialist, Supplier Quality Assurance External Manufacturing
Detalhes do emprego
KellyFSP is collaborating with one of our top-tier pharmaceutical client and seeking a Senior Specialist, Supplier Quality Assurance External Manufacturing to support quality assurance functions required for the API (Active Pharmaceutical Ingredients) Restructuring Project.Location: India (Pune or Hyderabad preferrable)Contract Duration: 12 months + potential extensionTravel: 50% mainly in India, another area as China also possibleKey responsibilities: Supporting supplier selection and qualificationProviding quality support for product transfers, process validations, and performing overall quality oversight of API manufacturersEnsuring that all products or materials supplied are manufactured, packaged, analyzed, and distributed in conformance to company and regulatory guidelinesSupporting and technical advice, guidance, and counselling to the external party quality representativeGuiding the external party to comply with Current Good Manufacturing Practices regulations and other pertinent legal requirementsPerforming due diligence and qualification auditsConducting regular site visits to support training and coaching to initiate quality improvementsQualifications:6-8 years of industry experienceBachelor's degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or equivalentExpertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirementsAPI experience (active pharmaceutical ingredients)Excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environmentsEnglish language capabilityPreferably to have auditor training or auditing experienceJoin us at KellyFSP and make a lasting impact in the dynamic field of life sciences. Apply now and take your career to new heights! PRB
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