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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GMP compliance, quality assurance oversight, and aseptic manufacturing processes, with a strong focus on documentation, risk assessment, and continuous improvement initiatives. Proficient in managing quality systems and supporting operational excellence in a regulated environment.
Highest-signal resume keywords
GMP ComplianceAseptic ManufacturingQuality Management Systems (QMS)Deviation ManagementRisk Assessment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GMP Documentation ReviewBatch Record ManagementSOP AuthoringCAPA ManagementChange ControlContamination ControlValidation ActivitiesMedia FillsSmoke StudiesQuality Oversight
Soft Skills
Organizational AbilityAttention to DetailMultitaskingProactive MindsetSolution-Oriented
Tools & Technologies
LIMSVeeva VaultTrackwiseElectronic Quality SystemsPaper-Based Quality Systems
Industry Keywords
CGxPEU Annex 1FDA RegulationsAseptic ProcessingGEMBA Walks
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Provide QA oversight for GMP manufacturing operations, ensuring compliance with cGxP, EU Annex 1, FDA, and internal quality standards.
- Support batch release readiness through timely review and completion of quality documentation.
- Conduct shop floor presence activities, including GEMBA walks and manufacturing observations, to maintain GMP compliance and inspection readiness.
- Review, approve, and author GMP documentation, including SOPs, batch records, risk assessments, and training records.
- Support deviations, investigations, CAPAs, change controls, and continuous improvement initiatives.
- Act as the primary QA contact for manufacturing operations, providing guidance on quality, compliance, and aseptic processing activities.
- Drive quality culture by coaching and supporting Manufacturing, Maintenance, and Quality teams on GMP, contamination control, and aseptic best practices.
- Participate in risk assessments, validation activities, media fills, smoke studies, and contamination control initiatives.
- Support internal and external inspections and maintain inspection-ready documentation.
- Contribute to operational improvement and project activities to enhance quality, compliance, and manufacturing performance.
Requirements
What you’ll need- Minimum Bachelors degree in a scientific discipline.
- Minimum 3 years’ experience in aseptic manufacturing within a Quality or Manufacturing capacity in a GMP-regulated environment, preferably utilizing RABS technology (Grade A & B) is a requirement.
- Working experience with QMS processes, both paper-based and electronic systems (e.g., Batch Records, LIMS, Veeva Vault, Trackwise, etc.).
- Understanding of GMP regulation and guidance, notably Annex 1 ‘Sterile Manufacture’ and FDA Aseptic Guide.
- Working experience with deviations, Investigations, and CAPAs.
- Strong organisational and coordination ability.
- High attention to detail and accuracy under pressure.
- Ability to multitask and manage shifting priorities effectively.
- Proactive and solution-oriented mindset.
Benefits
Comp & perks- Highly competitive salary
- Group pension scheme
- Private Medical Insurance for the employee
- Ongoing opportunities for career development in a rapidly expanding work environment
- Succession planning and internal promotions
- Education allowance
- Wellness activities
- Social activities eg. Golf, Padel, Summer Event