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
Contact Detail:
BioTalent Recruiting Team