Quality Assurance Specialist

About the Role

Sun Pharma invites applications for the position of Quality Assurance (QA) Specialist within its Global Quality & Compliance division, based in Mumbai. Embracing a culture of continuous improvement and empowerment, this role focuses on ensuring full compliance with Good Manufacturing Practices (GMP) and overseeing quality operations for biologics and branded pharmaceutical products.

Key Responsibilities

• Ensure adherence to GMP, Good Distribution Practices (GDP), and Marketing Authorization Holder (MAH) obligations under EU GMP and EMA regulations.
• Maintain comprehensive documentation and quality systems for all branded products.
• Supervise outsourced manufacturing and testing partners, including qualification status and performance KPI monitoring.
• Perform periodical risk assessments related to contract manufacturing organizations (CMOs).
• Compile and write annual product quality reviews.
• Assist in audit planning, manage audit schedules, archive audit evidence, and support both internal and external audit activities.
• Coordinate investigations into unplanned deviations, product complaints, and defects, ensuring thorough documentation and timely resolution through the QMS.
• Participate in recall preparations and notifications as needed.
• Support deviation management and CAPA follow-up related to quality issues.
• Track manufacturing site change requests and assess their GMP and MAH impact.
• Collaborate cross-functionally with teams including Regulatory Affairs, Pharmacovigilance, and Business to gather relevant information.

Required Qualifications and Experience

• Bachelor’s or Master’s degree in Biochemistry, Pharmacy, Pharmaceutical Business Administration, Biotechnology, or related Life Sciences field.
• Minimum of 5 years of relevant experience in pharmaceutical manufacturing, QA/QC, regulatory operations or contract manufacturing environments.
• Strong understanding of EU GMP regulations and US CFR standards.
• Proficient in Microsoft Excel and comfortable managing quality data and documentation.
• Fluent in English, both written and spoken.

Preferred Skills

• Experience managing Marketing Authorization Holder duties including PQRs, change control, complaints, and quality defect processes.
• Familiarity with electronic quality management systems such as EDMS, TrackWise, and LMS.
• Experience in contract manufacturing oversight and effective communication with external partners.
• Knowledge of regulatory processes for dossier updates, variations, and GMP compliance reporting.
• Strong analytical and data trending skills.
• Capability to work efficiently in fast-paced, multi-stakeholder environments.

Behavioral Attributes

• Accountable and dependable in managing quality responsibilities through to completion.
• Commitment to compliance, precision, and first-time-right execution.
• Clear and confident communicator capable of translating technical details into actionable insights.
• Proactive in suggesting quality and process enhancements.
• Open to constructive feedback and dedicated to personal growth.
• Ability to handle workload fluctuations without compromising quality.

Additional Information

The role involves occasional travel and requires interacting with multiple internal and external stakeholders to maintain operational compliance and quality assurance effectiveness. Sun Pharma fosters an environment supporting growth, collaboration, and achievement for all employees. The job description provides a general overview; tasks and responsibilities may evolve over time with organizational needs.