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Senior Quality Assurance

1 month ago

Hyderabad, India Kelly Science, Engineering, Technology & Telecom Full time

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

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