Quality Assurance Associate
About the Company
WhiteCrow is a global talent research, insight, and sourcing specialist with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our client is a leading Indian pharmaceutical company headquartered in Bengaluru with a footprint across 100 countries. The company manufactures pharmaceutical products, over-the-counter drugs, and nutraceuticals, operating two business verticals: Regulated Markets and Emerging Markets. Their manufacturing footprint includes 8 facilities across 4 continents, with 5 US FDA-approved sites and a dedicated R&D facility in India. They partner with generic companies in the US and Canada, supply retail and hospital generics, and maintain long-term relationships in European, Australian, and New Zealand markets.
Responsibilities
- Review documents/records and provide batch release authorization to 3PL service providers for products manufactured outside the US (with supervision).
- Support Drug Product Complaint management by forwarding to respective manufacturing sites and coordinating with corporate QA for investigations.
- Support Drug Product Recall/Field alert management.
- Assist with the review of Quality Agreements.
- Review deviations/investigations related to frontend products (with supervision).
- Assist with SOP management for the US corporate office.
- Support quality matters for the disposition of product returns.
- Assist during FDA inspections and local regulatory inspections at the US corporate office.
Requirements
- Excellent verbal and written communication skills.
- Ability to prioritize competing tasks in a fast-paced environment with supervision and direction.
- Motivated, results-driven with attention to detail, accuracy, and clarity.
Qualifications
- BS degree in Pharmacy, Chemistry, Biology, or Microbiology (preferred).
- 1-2 years of Quality Assurance or related pharmaceutical industry experience (preferred).
- Recent graduates will be considered for this role.