QA Specialist

Role Overview

This position sits within Global Quality & Compliance at Sun Pharma, based in Mumbai. The role supports quality assurance work for biologics and branded medicines, with a strong focus on GMP compliance, oversight of external manufacturers, upkeep of MAH-related records, and coordination across internal teams, partner sites, and regulators.

The role also helps protect the marketing authorisation holder’s responsibilities across the product lifecycle, including product quality, GMP obligations, deviations, recalls, complaints, and change management.

Key Responsibilities

• Assist with MAH duties in line with EU GMP and EMA expectations.
• Keep quality documentation and systems current for branded products and related compliance needs.
• Monitor and maintain qualification records for outsourced manufacturing and testing partners.
• Track KPIs with CMOs and support regular review of partner performance.
• Contribute to periodic risk assessments for each CMO.
• Prepare and compile annual product reviews for branded products.
• Support audit planning, audit scheduling, and maintenance of audit readiness.
• Collect and archive audit evidence and GMP confirmation records.
• Where needed, take part in CMO audits.
• Help prepare for external inspections and readiness reviews from partners, corporate quality teams, and regulators.
• Record, coordinate, and follow up on complaints and quality defect investigations until closure within the QMS.
• Support recall preparation, notices, and related documentation.
• Assist with deviation records and QMS documentation management.
• Track CAPAs linked to quality events and ensure timely follow-through.
• Monitor change requests at manufacturing sites and support GMP/marketing-authorisation impact assessment.
• Work closely with Business, Regulatory Affairs, and Pharmacovigilance teams to collect the information needed for quality activities.

Technical Skills

• Strong command of cGMP and QA/QC compliance requirements across US, EU, and other major health authorities.
• Practical experience with API/DS, drug product, and finished goods quality processes, including contract manufacturing oversight.
• Good understanding of change control and how it connects with regulatory requirements.
• Ability to assess manufacturing and analytical technical documents and prepare clear, well-supported QA decisions.
• Hands-on use of quality systems such as EDMS, LMS, and TrackWise.
• Working knowledge of risk assessment and risk management tools and methods.
• Experience collaborating with CMOs, testing labs, and other external service providers.
• Strong capability in Microsoft Office and Windows-based tools.

Behavioural Competencies

• Owns assigned tasks and delivers them through to completion.
• Works consistently and dependably on quality-related responsibilities.
• Shows a strong focus on compliance, accuracy, and first-time-right execution.
• Communicates clearly and confidently with people at all levels.
• Can turn technical information into practical, easy-to-understand messages.
• Looks for ways to improve processes and strengthen quality oversight.
• Welcomes feedback and supports personal growth.
• Manages peak workloads without sacrificing quality.

Job Requirements

• Bachelor’s or Master’s degree in Biochemistry, Pharmacy, Pharmaceutical Business Administration, Biotechnology, or another related life-science field.
• At least 5 years of experience in a pharmaceutical setting such as manufacturing, QA/QC, regulatory operations, or contract manufacturing.
• Strong working knowledge of EU GMP and US CFR requirements.
• Comfortable working with Excel, data, and quality documentation.
• Fluent written and spoken English.

Preferred Experience

• Experience supporting MAH-related activities such as product quality reviews, change control, complaints, and quality defects.
• Familiarity with quality IT systems such as EDMS, TrackWise, LMS, or similar QMS platforms.
• Background in contract manufacturing oversight and communication with external partners.
• Understanding of regulatory processes tied to variations, dossier updates, and GMP reporting.
• Strong analytical ability, including trending and monitoring quality data.
• Ability to work effectively in a fast-moving, cross-functional environment with many stakeholders.

Additional Information

Business Unit: Global Quality & Compliance

Job Grade: G10

Location: Mumbai, Mumbai Metropolitan Region

Experience: 12 to 14 years

Travel Estimate: Not specified

Company Note

Sun Pharma describes its culture as one built around continual improvement, ownership, and teamwork, with an emphasis on helping employees grow, take charge of their work, and succeed together.

Disclaimer

This description reflects the general nature and level of work expected for the role. It is not a complete list of all duties, responsibilities, or qualifications, and the employer may update duties or assign similar work as needed based on business requirements and the incumbent’s experience.