Senior Specialist, Supplier Quality Assurance External Manufacturing

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!