Quality Assurance Associate

BioTalent
Reading
3 days ago
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We are currently looking for a QA Associate to join a leading pharmaceutical company on a 9 month contract.

Please make sure you read the following details carefully before making any applications.

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 systemsProficient in documentation review and risk-based decision makingHigh attention to detail with accurate data entry skillsStrong communication and interpersonal skillsExcellent organizational, planning, and time-management abilitiesIT literate (MS Office; familiarity with databases)Preferred Experience:Prior experience in a GMP-regulated environmentWorking knowledge of deviations, CAPAs, and quality investigationsInvolvement in continuous improvement or pharmaceutical quality system (PQS) enhancement projects

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