QA Specialist

Job Grade

Location :

Mumbai

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment 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.