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To be responsible for maintaining compliance within the Stability Suites, Stability Laboratory, and associated areas to support the determination of product shelf-life and product labelling. The focus of this role will be on Non-Conformance (NC), Corrective Action/Preventative Action (CAPA), and Out of Specification (OOS) investigations.
Key Responsibilities:
* Maintain compliance with ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.
* Support maintenance, calibration, documentation, and updating quality records for Stability equipment.
* Support on-site maintenance, service, and calibration activities performed by external vendors.
* Act as Subject Matter Expert (SME) and write Quality documentation such as Change Control Requests (CCRs), Non-Conformances (NCs), CAPAs, and Laboratory Out of Specifications (OOS), ensuring thorough investigations within required timeframes, and incorporate problem-solving for future improvements.
* Monitor compliance KPIs within the Stability department and proactively update management with trends and improvement initiatives.
* Ensure the Stability department is audit-ready at all times.
* Support and provide information for internal and external audits in a timely manner.
* Conduct training sessions on compliance for the Stability department.
* Support global testing laboratories with compliance requirements as needed.
* Implement improvement ideas (Lean/6S) for the Stability laboratories and suites.
* Support the implementation of the LIMs system.
* Assist with bringing in new equipment through planning and execution of Installation, Operational, and Performance Qualification activities, liaising with vendors as per procedures.
* Maintain the Safety and Compliance of the Stability lab, Suites, and storerooms, raising near misses when needed.
* Support other tasks as required by the Laboratory Manager/Team Leaders.
Skills & Experience:
* Preferably 2-3 years’ experience in Medical Device/Pharmaceutical Industry in R&D/product development or quality.
* Ability to adapt to changing priorities and workloads.
* Experience following stability study protocols, SOPs, OCIs, and TDs.
* Basic experience with computerised systems for data management.
* Good knowledge of Microsoft Office, especially Word and Excel.
* Understanding of FDA and European Regulations (ICH), Quality Systems, and GMP guidelines.
* Proactive, positive, and open to change and new ways of working.
* Experience leading quality investigations and implementing preventative and corrective actions.
Strong communication skills for cross-functional collaboration.
Qualifications/Education:
* B.Sc. or equivalent in a scientific discipline (e.g., Chemistry, Biology).
Seniority level
* Associate
Employment type
* Contract
Job function
* Quality Assurance and Research
Industries
* Medical Equipment Manufacturing
This job posting is active.
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