16 Aug
|
SUN PHARMA
|
Mumbai
Job Title
QA Specialist
Business Unit
Global Quality & Compliance
Job Grade
G10
Location :
Mumbai
At Sun Pharma, we commit to helping you “
Create your own sunshine
”— by fostering an setting where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Summary
The QA Specialist/Manager supports in activities for Biologics and Branded medicinal products by ensuring operational GMP compliance, coordinating oversight of external manufacturers, maintaining MAH‑required documentation, and facilitating communication between internal teams, manufacturing sites, and regulatory authorities.
The QA Specialist/Manager is responsible for supporting the department in maintaining compliance across all stages of the product lifecycle and ensuring the proper maintenance of quality systems
This role strengthens the MAH’s legal responsibilities in relation to GMP, product quality, unplanned deviations, recalls, product quality complaints and change management.
Key Responsibilities
- GMP/GDP & MAH Compliance
- Support execution of MAH responsibilities as required under EU GMP and EMA MAH expectations.
- Maintain documentation and systems ensuring compliance for all branded products.
- Oversight of Outsourced Activities
- Maintain and update Qualification status for outsourced manufacturing/testing partners.
- Ongoing KPI’s monitoring with key CMO’s
- Periodical Risk assessment evaluated risks per CMO.
- Writing/compiling Annual product reviews for branded products
- Audit & Qualification Support
- Assist in planning and maintaining the audit schedule
- Collect audit evidence, and GMP confirmation d
📌 QA Specialist (Mumbai)
🏢 SUN PHARMA
📍 Mumbai