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Quality Assurance Associate (Reading)

BioTalent
Reading
2 months ago
Applications closed

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We are currently looking for a QA Associate to join a leading pharmaceutical company on a 9 month contract.


Key Responsibilities:

  • Quality & Compliance Support:Monitor and assess site operations for compliance with GMP and internal procedures, identifying and escalating non-conformances through appropriate QMS channels.
  • Documentation Review:Perform detailed, real-time review of manufacturing and laboratory documentation, ensuring accuracy, completeness, and adherence to regulatory standards.
  • Continuous Improvement & Audit Readiness:Contribute to a state of audit readiness by actively participating in quality system improvements and continuous improvement initiatives.
  • Compliance Issue Management:Utilize in-depth GMP and QMS knowledge to manage and escalate major and critical quality issues, including deviations and CAPAs.
  • Cross-Functional Collaboration:Serve as a quality liaison for key stakeholders across manufacturing, technical operations, and supply chain teams.
  • Training & Best Practice Promotion:Mentor team members on cGMP principles and best documentation practices, supporting a culture of compliance and proactive quality.


Required Skills & Competencies:

  • Strong knowledge of GMP and pharmaceutical quality systems
  • Proficient in documentation review and risk-based decision making
  • High attention to detail with accurate data entry skills
  • Strong communication and interpersonal skills
  • Excellent organizational, planning, and time-management abilities
  • IT literate (MS Office; familiarity with databases)

Preferred Experience:

  • Prior experience in a GMP-regulated environment
  • Working knowledge of deviations, CAPAs, and quality investigations
  • Involvement in continuous improvement or pharmaceutical quality system (PQS) enhancement projects
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