Operational Quality Specialist - MES

About the role

GSK manufactures and supplies medicines and vaccines, and is looking for an Operational Quality Specialist focused on its Manufacturing Execution System (MES). The role ensures adherence to cGxP standards through independent oversight of GxP processes, supports operational quality assurance for MES activities that support drug product manufacturing, and works closely with manufacturing, engineering, IT and quality teams to keep processes compliant and data trustworthy.

Key responsibilities

• Provide operational QA oversight for MES workflows, electronic batch records and system-controlled manufacturing steps.
• Ensure GMP processes and personnel comply with GMP, validation, quality, safety and environmental regulations, keeping inspection readiness.
• Review and approve changes to master data (equipment, sMBR, workstations, workcenters), URS and design of Main-PI and Sub-PI, validation forms, risk assessments, IO/PQ protocols and audit trails.
• Develop and approve MES LSOPs and their child documents.
• Review, approve and coach on deviations, CAPA plans, logbooks, PQRs, change controls, validation documents and customer complaint investigations.
• Lead or support investigations of deviations, system incidents and data anomalies, including root cause analysis and CAPA follow-up.
• Support inspection readiness, internal audits and regulatory questions on computerized systems, monitor MES quality KPIs and recommend improvements.
• Coach staff on data integrity and GxP standards, and perform regular shopfloor and system walkthroughs.

Required profile

• Bachelor's degree in Life Sciences, Biology or Chemical Engineering; other degrees acceptable with equivalent technical depth.
• At least 3 years' experience in a regulated industry, preferably in Quality Assurance, with prior MES implementation experience.
• 1+ year of hands-on experience with GMP and GDDP.
• Training and experience in DMAIC root cause analysis.
• Preferred: biologics manufacturing experience, familiarity with 21 CFR Part 11 or Annex 11, hands-on system validation (IQ/OQ/PQ) experience, and experience with LIMS or electronic batch records.

Required skills

• Understanding of GMP, validation principles, aseptic processing, quality systems and FDA regulations.
• Knowledge of pharmaceutical facilities, equipment and systems.
• Ability to influence cross-functional teams, coach colleagues and communicate clearly in a fast-paced environment.