Senior Specialist, Supplier Quality Assurance External Manufacturing

  • Hyderabad
  • Kelly Science, Engineering, Technology E Telecom
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 extension Travel: 50% mainly in India, another area as China also possible Key responsibilities: Supporting supplier selection and qualification Providing quality support for product transfers, process validations, and performing overall quality oversight of API manufacturers Ensuring that all products or materials supplied are manufactured, packaged, analyzed, and distributed in conformance to company and regulatory guidelines Supporting and technical advice, guidance, and counselling to the external party quality representative Guiding the external party to comply with Current Good Manufacturing Practices regulations and other pertinent legal requirements Performing due diligence and qualification audits Conducting regular site visits to support training and coaching to initiate quality improvements Qualifications: 6-8 years of industry experience Bachelor’s degree in Veterinary, Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or equivalent Expertise and broad experience in Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP and regulatory requirements API experience (active pharmaceutical ingredients) Excellent problem-solving skills, based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments English language capability Preferably to have auditor training or auditing experience Join us at KellyFSP and make a lasting impact in the dynamic field of life sciences. Apply now and take your career to new heights!