At a Glance
- Tasks: Ensure quality compliance and oversee GMP processes in a dynamic environment.
- Company: Join a leading pharmaceutical company committed to quality and patient safety.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Inclusive workplace with a focus on continuous improvement and career development.
- Why this job: Make a real impact on product quality and patient safety in the healthcare industry.
- Qualifications: Bachelor’s degree in a relevant field and experience in QA within regulated industries.
The predicted salary is between 35000 - 45000 £ per year.
Key Responsibilities
- Quality Oversight
- Ensure GMP processes and operational personnel adhere to governing procedures, minimising risk of non‑compliance and maintaining inspection readiness.
- Maintain presence across area of responsibility and act as the first line of contact to support initial management of quality issues, including initial impact assessment for deviations.
- Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real‑time, allowing for timely interventions to prevent deviations and defects.
- Perform spot‑checks of activities for the oversight areas to ensure compliance with quality standards.
- Ensure adherence to the frequency of oversight mandated in the Quality oversight schedule.
- Review batch‑related documentation and records to ensure that the content meets ALCOA+ principles.
- Check that facilities are maintained in a good state in line with local housekeeping standards; any deviation is escalated with associated actions addressed timely.
- Authorize campaign changeovers and participate in facility walkdowns where required.
- Participate in production tier meetings to provide input on managing quality issues and follow up.
- Foster a "Quality Starts With Me" (QSWM) culture by coaching employees on the importance of following procedures, doing the right thing, and explaining the impact of non‑compliance on product quality and patient safety.
- Authorization Activities
- Authorize QA processes such as quality tagouts, conditional equipment releases, campaign changeovers, and room releases.
- Decide compliance status for QC testing, validation issues, batch usage, record closures, and processing or release suitability.
- Documentation Review and Approval
- Review and approve executed batch records and related checklists; take batch usage decisions for sterile buffers, bulk and/or drug substance intermediates as assigned.
- Review and approve procedures, checklists, master batch records, deviations, CAPAs, change controls and quality tag‑out related to manufacturing operations as assigned.
- Training and Subject Matter Expertise
- Own and maintain relevant SOPs and checklists, train personnel, and support self‑inspections and audits.
- Act as a subject‑matter expert (SME), implement quality process improvements, coach junior staff (for Senior position), and stay updated with best practices.
- Other QA Support Activities
- Support periodic quality product reviews and site key performance indicator (KPI) reporting.
- Perform internal audits and risk assessments/gap analyses as part of continuous quality improvement efforts.
- Basic Qualifications
- Bachelor’s degree in life science, pharmacy, engineering, chemistry or related technical discipline.
- Minimum 2 years of experience within pharmaceutical, biotechnology, medical device or related regulated industry for QA Executive.
- Preferably 5 years of experience within pharmaceutical, biotechnology, medical device or related regulated industry for Senior QA Executive.
- Demonstrated knowledge of GMP standards and regulatory requirements, and ability to operate effectively within the pharmaceutical quality systems.
- User experience with Quality Management Systems (QMS) and effective communication within the site.
- Ability to apply risk‑management skills and risk‑based approach adequately.
- Ability to apply quality assurance standards and promote quality as a competitive advantage.
- Ability to solve simple or lower‑impact investigations.
Skills
Data Integrity, Detail‑Oriented, Digital Fluency, Gx P Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing
Equal Opportunity Statement
We are committed to creating an inclusive workplace and providing equal opportunities for all applicants.
Important Notice to Recruitment Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
In the absence of such written authorization, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
GSK shall therefore not be liable for any fees arising from such actions or any referrals by employment businesses/agencies.
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