Title:  QA Specialist

Job Title:

QA Specialist

Business Unit:

Sun Global Operations

Job Grade

G10

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.
• 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 documents in comprehensive archive.
• (optional) participate in CMO audits.
• Support in planning and inspections readiness for external audits (from partners, corporate quality systems and regulatory authorities)

• Unplanned deviations, Complaints & Recalls
• Log and coordinate complaint and quality defect investigations with manufacturers, and ensure their progression through the QMS to satisfactory and timely closure.
• Support in recall preparation, notifications, and documentation
• Support in deviation management documentation in QMS
• Track and follow up on CAPAs related to quality issues.

• Change Control Support
• Track manufacturing site change requests and support QA in evaluating GMP/MA impact

• Collaboration with cross departments
• Collaborate with cross‑functional departments, including Business, RA, and PVG, to gather necessary information as needed.

Technical skills/job specific competencies

• Strong cGMP knowledge and experience in QA/QC and regulatory compliance across US, EU, and other international health authorities.
• Advanced experience with API/DS, Drug Product, and Finished Goods QA/QC processes, including contract manufacturing oversight.
• Solid understanding of complex change control processes and their interaction with regulatory affairs requirements.
• Capable of reviewing and assessing manufacturing and analytical technical documents and providing high‑quality, well‑reasoned QA assessments.
• Proficient in using Quality IT systems such as EDMS, LMS, and TrackWise.
• Good understanding of risk assessment and risk management principles, tools, and methodologies.
• Experience in interacting effectively with external partners, including CMOs, testing laboratories, and service providers.
• Strong proficiency with Microsoft Office and other Windows‑based applications

Behavioral Skills/Competencies (e.g. excellent communication skills, strong collaborator, Problem solving etc.)

• Takes responsibility for assigned tasks and follows through to completion.
• Demonstrates reliability and consistency in managing quality‑related activities.
• Strong commitment to compliance, accuracy, and right‑first‑time execution.
• Clear, structured, and confident communicator across all organizational levels.
• Able to translate technical information into understandable, actionable messages.
• Proactively identifies opportunities to improve processes and quality oversight.
• Open to feedback and committed to personal development.
• Able to manage workload peaks without compromising quality.

Travel Estimate

Job Requirements

Educational Qualification

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

Preferred

• Experience in working with or supporting MAH responsibilities (e.g., PQRs, change control, complaints, quality defects).
• Familiarity with quality IT systems (EDMS, TrackWise, LMS, or similar QMS platforms).
• Experience with contract manufacturing oversight and external partner communication.
• Understanding of regulatory processes linked to variations, dossier updates, and GMP reporting.
• Strong analytical skills, including trending and quality monitoring.
• Ability to work in a fast‑paced, cross‑functional environment with multiple stakeholders.

Experience

Tenure:  12 to 14 Yrs

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).