Planet Pharma are seeking a dedicated and experienced Quality Assurance Specialist to join our team. In this role, you will support operations to ensure compliance with Good Manufacturing Practices (GMP) and manage GMP issues through Quality Management System (QMS) processes, site governance, and senior QA leadership. As a GMP Subject Matter Expert (SME), you will implement, manage, and enforce quality processes on site, supporting senior QA leadership to drive continuous improvement and maintain compliance with regulatory authorities, global quality standards, and customer expectations.
Key Responsibilities:
- Compliance Support: Ensure operations comply with GMP standards.
- GMP Issue Management: Manage and support GMP issues through QMS processes, site governance, and senior QA leadership.
- Quality Processes: Implement, manage, and enforce quality processes on site.
- Continuous Improvement: Support senior QA leadership to drive continuous improvement and maintain compliance with regulatory authorities, global quality standards, and customer expectations.
- Quality Records Management: Provide review, approval, and support for the management of quality records (e.g., Deviations, CAPA, Change Controls, Investigations, OOS).
- Compliance Issue Escalation: Manage and escalate major and critical compliance issues through site QMS processes.
- Audit Readiness: Maintain and promote a state of audit readiness.
- Process Improvement Initiatives: Suggest, initiate, participate, and contribute to PQS process improvement initiatives and projects.
- QA SME Support: Provide QA SME support at departmental Local Quality Councils, project meetings, and during out-of-hours manufacturing.
Qualifications:
- Proven experience in GMP compliance and quality assurance.
- Strong knowledge of GMP and quality processes.
- Excellent problem-solving and analytical skills.
- Strong communication and teamwork abilities.
- Ability to mentor and coach others in cGMP practices.
- Proactive and independent working style
Previous experience as QA approver of Deviations, CAPAs, Change Controls would be essential.
To Apply:Click Apply or contactJack Pearne at Planet Pharmafor more information:
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
