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Job Purpose
To ensure in-process monitoring of production and related activities, and to make sure Quality Assurance processes are effectively implemented in Production Operations and Quality Operations. This role supports the manufacture of products in line with GSK and regulatory specifications and drives continuous improvement to make processes more robust.
Key Responsibilities
Ensure in-process checks during manufacturing, filling, and packing are performed as per BMR/BPR and SOPs, taking timely corrective actions to mitigate risk.
Oversee end-to-end production activities (material issuance, dispensing, manufacturing, filling, packing) to maintain QMS, cGMP and licensing compliance.
Support and strengthen Data Integrity on the shop floor by enforcing ALCOA(+) principles and site Data Integrity controls.
Support product release by compiling and reviewing batch documents, ensuring releases meet regulatory, cGMP and QMS requirements, and retaining batch dossiers per local/GSK policy.
Manage archive, batch document, and retained sample rooms, ensuring proper storage, traceability, access control and compliance with retention procedures.
Report deviations and support their rectification; advise line management, lead investigations into product quality issues and ensure appropriate CAPAs are implemented.
Coordinate and support investigations for OOS or nonconforming products and liaise with stakeholders to prepare, implement and track CAPA plans.
Execute validation protocols on the shop floor and provide Operational Qualification (OQ) input to site validation activities.
Maintain EHS standards in Operational Quality: report adverse events, drive ZIP/ZAP/ZWP actions and participate in safety initiatives to promote zero accidents, zero defects and zero waste.
Support other Operational Quality teams and continuous improvement projects and perform additional tasks or projects as assigned by the manager.
Education, Experience and Skills
Bachelors in Applied Chemistry, Chemistry, Chemical technology, or Pharm D
0 – 1 year of experience in Quality Assurance, or operational quality (floor exposure preferred).
Strong understanding of QMS, GMP, data integrity and regulatory requirements.
Demonstrated experience in deviation handling, investigations, CAPA management and validation activities.
Familiarity with EHS practices and continuous improvement tools.
Strong attention to detail, problem-solving skills, and ability to collaborate with cross-functional teams.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Contact information:
You may apply for this position online by selecting the Apply now button.
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