We are a pharmaceutical company committed to providing access to affordable and innovative medicines. We are driven by our purpose of ‘Good Health Can’t Wait’. We offer a comprehensive portfolio of products and services including Active Pharmaceutical Ingredients (API), generics, branded generics, biosimilars and over-the-counter pharmaceutical products across the world. Our therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. We are investing in businesses of the future including drug discovery, clinically-differentiated assets and digital healthcare.
Job Description
- Post: Team Lead Quality Assurance
- Department: Biologics
- Qualification: B Pharm
- Experienced: 7 to 12 Years
- Work Location: Hyderabad
Key Responsibilities:
Lead and support in hosting all external or internal regulatory, customer, partner audits.
Scheduling the audit readiness meetings & Information sharing on audit readiness for scope, previous learnings, other units or other industry learnings.
Coordinating with the stake holders on having all the relevant information (incidents, complaints, batches, OOSs, OOTs, Excursions and so on) available for audit.
Identifying the team (scribe, scribe receiver, runner, back room, and so on) required for audit management.
Scheduling the opening meetings, daily briefing meetings, audit closing meetings.
Documenting the audit observations, notes, schedules, and audit learnings
Supporting the Documentation Cell ready towards the audit operations for right documents,
Coordinating with the stake holders for compliance assessment on new or revised regulatory guidelines and presenting a strategy plan towards implementation at site.
Leading the Quality Management System for Biologics across the domains including development & operations.
Working towards harmonizing the site’s Quality Assurance procedures with DRL global procedures.
Tracking all the DePex development projects towards Quality Operations and making sure that they are timely implemented at site.
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