Quality Assurance Associate

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:

• Primary responsibilities of this role include the following:
• With Supervision, review documents/records and provide batch release authorization to 3PL service provider for products manufactured outside of the US.
• Support Drug Product Complaint management; forwarding to respective drug product manufacturing site and coordinate with corporate QA for investigations.
• Support Drug Product Recall/Field alert management.
• Assist with review of Quality Agreements.
• For applicable products, coordinate with Contract Testing Laboratories for Analytical Method Transfer activities, Drug Product testing, any OOS results, and test method issues.
• With supervision, review deviations/investigations related to the company's frontend products.
• Assist with SOP management for the company’s US corporate office.
• Support with quality matters for disposition of product returns.
• Assist during FDA inspections and local regulatory inspections at the company’s US corporate office.

Requirements:

• Excellent verbal and written communication skills are necessary.
• With supervision and direction, effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Motivated, results driven with attention to detail, accuracy and clarity.

Qualifications: 

• BS degree in Pharmacy, Chemistry, Biology or Microbiology is preferred. 1-2 years of Quality Assurance or related pharmaceutical industry experience is preferred.
• Recent graduates will be considered for this role.