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Planet Pharma is pleased to be recruiting for a QA Specialist to work for a leading organisation in the UK. This role is responsible for supporting the enrolment and maintenance of the global standards process, ensuring smooth implementation and management of critical documentation and quality systems. The successful candidate will play a key role in maintaining compliance, coordinating system implementation, and serving as a point of contact for stakeholders.
Key Responsibilities
1. Provide shoulder-to-shoulder review of documentation generated during manufacturing, development, and laboratory processes.
2. Advise on best practices for document completion, review, follow-up actions, and escalate issues when necessary.
3. Act as a point of contact for general quality-related queries and escalate as required.
4. Utilize knowledge of quality procedures to identify, report, and resolve non-conformances via interaction with relevant personnel.
5. Manage and escalate major and critical compliance issues through site QMS processes, including deviations and CAPAs, using GMP knowledge.
6. Identify, suggest, and participate in continuous improvement activities.
7. Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment.
8. Maintain and promote audit readiness.
9. Contribute to PQS process improvement initiatives and projects.
Qualifications
Education/Degree
Required: Bachelor's of Science (or equivalent experience) in Biology or a related field.
Work Experience
Previous experience in QA / GMP is useful but not essential.
Additional Skills
* Risk-based decision making
* PQS experience
* Accurate data entry skills with high attention to detail
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