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A dynamic pharmaceutical company committed to advancing healthcare through innovative vaccine solutions. We are currently seeking a highly motivated and detail-oriented individual to join our Quality team in the role of QC Bioassay Analyst.
Responsibilities:
Perform laboratory testing, data review, and data interpretation in compliance with approved Standard Operating Procedures (SOPs), ensuring adherence to cGMP standards (EU GMP Annexes and FDA CFRs) and high standards of Health, Safety, and Environment (HSE).
Complete critical tasks such as instrument maintenance, calibration, reagent and standard qualification, initiation of deviations, CAPAs, change control actions, SOP updates, and participation in quality risk assessments.
Participate in laboratory administration tasks, including HSE risk assessments, archiving of laboratory documentation, ordering reagents and consumables, maintaining QC sample and reagent stores, and ensuring a clean and safe workplace.
Proactively maintain training records and only perform tasks for which compliance training has been confirmed, following local SOPs.
Communicate professionally and effectively with fellow team members and the QC Bioassay leadership team.
Accountability Description:
- Report findings promptly to the QC Bioassay leadership team, highlighting deviations or compliance gaps immediately.
- Take responsibility for instrument maintenance, calibration, deviations, CAPAs, change control actions, SOP updates, and quality risk assessments.
- Manage laboratory administration tasks and maintain a clean, safe workplace.
- Proactively maintain training records and adhere to compliance standards.
- Communicate professionally with team members and leadership.
Job Criteria:
- Key member of the Quality team supporting timely product testing and release.
- Liaise with QC, QA, Supply Chain, Engineering, Manufacturing, and GLIMS team members.
- Represent the department at inter-departmental meetings as required.
Internal and External Stakeholders:
Key internal relationships include QC Bioassay team members, QC Analytical, QC Microbiology, QC Validation, QC Stability, GLIMS, QA, Internal Engineering, Manufacturing, and Supply Chain team members.
Problem-Solving and Improvement:
- Identify and solve complex problems related to testing, equipment issues, failures, breaches of specification, compliance gaps, and prioritize using a quality risk-based approach.
- Identify potential improvements to the laboratory operating environment.
Knowledge, Skills & Competencies:
- Fluent in English.
- Experience in QC testing techniques relevant to the role.
- Experience in cGMP application.
- Awareness of equipment and method validation requirements.
- Awareness of root cause analysis.
- Computer literate with an understanding of electronic systems.
Minimum Experience Requirements:
- Education: NVQ Level 2 or equivalent in a relevant scientific discipline.
- Experience: Relevant testing discipline experience, ideally within the pharmaceutical industry and cGMP standards.
If you are a highly motivated individual with a commitment to excellence in pharmaceutical testing, we encourage you to apply. Join our team and contribute to advancing healthcare through innovative vaccine solutions
