Analytical Quality Assurance Specialist

Our client is a leading Indian pharmaceutical company, headquartered in Bengaluru and a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals. They operate two business verticals, Regulated Markets and Emerging Markets. Their manufacturing footprint covers 8 manufacturing facilities in 4 continents, including 5 US FDA approved facilities and a dedicated R&D facility in India with global filing capabilities.

The company partners with generic companies in US and Canada, to supply retail and hospital generics in injectable products and soft gels. In European markets, it has long-term relationships for the development of projects and supply agreements. In Australia and New Zealand, the company is engaged in manufacturing and supply of soft gels and value-added manufacturing.

Responsibilities:

• Material/Product Review & Release:
• Review raw material and finished product testing result records, including Certificates of Analysis (C of A), Certificates of Conformance (C of C), and laboratory reports to confirm accuracy.  
• Determine the acceptability of materials/products for release based on compliance with specifications and testing results.  
• Perform ERP transactions for the release, hold, or rejection of raw materials and finished products.  
• Prioritize raw material review and release based on production scheduling requirements.  

Requirements:

• Minimum 5-12 years of experience in the pharmaceutical industry related to material/product review, release, and laboratory functions.  
• Expertise in reviewing and managing GMP documents, raw material and product testing, and quality systems.  
• Proficiency with laboratory systems and software tools such as LIMS, SAP, and EMPOWER.  
• Strong understanding of regulatory guidelines, including FDA, EMA, and ICH, as well as industry standards and best practices.