Title:  QA Associate I - Batch Record Reviewer

 Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.

As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being.

Are you passionate about quality and excited to support the release of products that make a difference? Join our Quality Assurance team as a QA Associate I, where you’ll play a key role in ensuring every batch meets the highest standards of compliance, accuracy, and documentation excellence.

In this role, you’ll apply your attention to detail and cGMP knowledge to support batch record review, deviation identification, compliance activities, and readiness for regulatory inspections. You’ll collaborate cross-functionally, contribute to quality initiatives, and help maintain our culture of audit-readiness and continuous improvement.

Area Of Responibility: 

As a QA Associate I, you will support the end‑to‑end quality process, including:

Batch Review & Release

• Review and release Commercial, Process Validation, and Exhibit batches.
• Execute conditional and final Usage Decisions in SAP.
• Identify deviations during BMR/PBR review and initiate TrackWise deviations when required.
• Manage batch record closure and document archival.

Quality Systems & Compliance Support

• Support DEA inventory management and annual retain sample inspections.
• Assist with annual stability sample tracking and submission.
• Prepare QA reports and PowerPoint presentations for review and release activities.
• Support ongoing MBR/PBR review and archival processes and product quality complaint investigations as needed.

Audit & Regulatory Readiness

• Support FDA (GMP & Pre‑Approval) and customer audits through document preparation, response coordination, and general audit‑readiness tasks.
• Provide required input for Annual Product Reviews.

General QA Support

• Maintain accurate documentation aligned with cGMP expectations.
• Complete additional assignments as directed by the Senior Associate or IPQA Section Head.

Work Environment:

You will work across office, lab, and manufacturing environments with moderate noise levels. This role requires comfort navigating dynamic production and quality spaces and following all required safety protocols.

Work Schedule:

• Monday-Friday 9:00am-5:30pm. (Flexibility to work over time on weekedns as needed)

Physical Requirements:

• Ability to stand, walk, sit, bend, stoop, kneel, crouch, crawl, push, and lift up to 20 lbs.
• Ability to move throughout office, laboratory, and manufacturing areas.
• Must be able to wear required PPE (e.g., respirators, gloves, safety glasses, safety shoes).

Travel: 0%

What You Bring:

Education & Skills

• Bachelor’s degree required.
• Understanding of GMP requirements.
• Proficiency in MS Office (Word, Excel, Outlook, PowerPoint), Acrobat, SAP, TrackWise or similar QMS, and LMS systems.
• Strong verbal and written communication skills.
• Excellent organizational skills with the ability to manage multiple priorities.
• A proactive, self‑starting mindset with a hands‑on, solutions‑oriented approach.
• English language proficiency at CEFR Intermediate B1+.

Experience

• Minimum 2 years of experience in the pharmaceutical industry in a quality role.
• Experience with solid oral dosage forms.
• Experience working in a multicultural, matrixed organization.

Why Join Us?

• Make a direct impact on product quality and patient safety.
• Work with a supportive, collaborative quality team.
• Gain exposure to key QA systems, audits, and regulatory expectations.
• Build a strong foundation for growth within the Quality function.

Ready to make a difference? Apply today and help us uphold the highest standards inpharmaceutical compliance!