About The Position

This role supports and leads Quality Management System (QMS) and quality oversight activities at our site in India. The position works closely with manufacturing, engineering, regulatory and supply teams to ensure safe, compliant and timely product supply. The role offers hands-on impact, visible career growth, and the chance to contribute to GSK’s mission of uniting science, technology and talent to get ahead of disease together. This role will provide the opportunity to lead key activities to progress career. The role is on-site in India. Regular presence on the production floor and active participation in cross-functional meetings are required. We welcome applicants who bring curiosity, honesty and a practical focus on quality and patient safety. We are committed to inclusion and encourage people from different backgrounds and experiences to apply.

Requirements

  • Bachelor/ Master’s degree in pharmacy, or life sciences, chemistry, biotechnology or equivalent
  • Minimum 5 years’ experience in Good Manufacturing Practice (GMP)/ Quality Management System operations or quality assurance in a regulated manufacturing environment.
  • Practical knowledge of GMP and quality management systems.
  • Experience participating in investigations, deviations and CAPA activities.
  • Reasonable knowledge of Drugs and Cosmetics Act + Schedule M and acquaintance of international regulatory expectations.
  • Good communication skills in English and ability to work with cross-functional teams.

Nice To Haves

  • Master’s degree in pharmacy, life sciences, chemistry, biotechnology.
  • Experience with advance computer skills, electronic batch records, manufacturing execution systems or SAP quality transactions.
  • Prior participation in internal or external audits and inspection readiness activities.
  • Familiarity with root cause analysis and continuous improvement tools.
  • Experience of leading and supporting quality improvement projects.
  • Knowledge of Indian and international regulatory requirements relevant to manufacturing and distribution.

Responsibilities

  • Provide day-to-day quality oversight of Quality management systems in production and Quality Control to ensure activities follow Good Manufacturing Practice and Good Documentation Practice according to laid down systems and procedures.
  • Execute and maintain local QMS processes, including change control, CAPA and risk assessments.
  • Management of QMS documentation, including review, issuance, archival and disposition.
  • Lead and support investigations into deviations, incidents and customer complaints.
  • Perform and support internal audits, self-inspections and routine quality reviews to maintain all-time inspection readiness.
  • Tracking and ensuring meeting of KPI targets.
  • Execute gap assessments and actions for implementation of GSK and regulatory systems and pharmacopoeia.
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