QA Specialist

Responsibilities

• Ensure operational GMP/GDP and MAH compliance for Biologics and Branded medicinal products.
• Oversee outsourced manufacturing and testing partners, including KPI monitoring and periodic risk assessments.
• Support the audit schedule, collect evidence, and assist in inspection readiness for regulatory authorities.
• Manage unplanned deviations, product quality complaints, and recalls through the QMS.
• Track and follow up on CAPAs and manufacturing site change requests to evaluate GMP/MA impact.
• Collaborate with cross-functional departments including Business, Regulatory Affairs, and Pharmacovigilance.

Requirements

• Bachelors or Masters degree in (Bio)chemistry, Pharmacy, Biotechnology, or a related Life Science field.
• Minimum of 5 years of experience in a relevant pharmaceutical environment (QA/QC, manufacturing, or regulatory operations).
• Strong knowledge of EU GMP and US CFR requirements.
• Proficient in Microsoft Excel and comfortable working with complex quality documentation.
• Fluent in English, both written and verbal.

Preferred Qualifications

• Experience supporting MAH responsibilities such as PQRs, change control, and quality defects.
• Familiarity with Quality IT systems including EDMS, TrackWise, or LMS.
• Experience with contract manufacturing organization (CMO) oversight and external partner communication.
• Understanding of regulatory processes linked to variations and dossier updates.

About the Company

Sun Pharmaceutical Industries Ltd is a global pharmaceutical leader dedicated to helping employees "Create your own sunshine" through a supportive community and continuous professional growth.