Position Overview:
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 to ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.
* Support maintenance, calibration, documentation and updating quality records for Stability equipment.
* Support any on-site maintenance, service and calibration activities performed by external vendors.
* Act as Subject Manner Expert (SME) and write Quality documentation such as Change Control Requests (CCRs), Non-Conformances (NCs), Corrective Action/Preventative Action (CAPAs) and Laboratory Out of Specifications (OOS'), ensuring accurate and thorough investigations are complete within required timeframes, incorporating problem-solving and troubleshooting for future improvements.
* Monitor compliance KPIs within the Stability department and proactively update the management team with trends and improvement initiatives.
* Ensure the Stability department is audit ready at all times.
* Supports and provides information for internal and external audits where required in a timely manner.
* Conduct training sessions on compliance for the Stability department.
* Support global testing laboratories with compliance requirements as needed.
* Actively execute improvement ideas (Lean/6S) for the Stability laboratories and suites.
* Actively supporting with the implementation of the LIMs system.
* Support bringing in new equipment when required, through planning and execution of Installation, Operational and Performance Qualification activities, liaising with vendors as per client's procedures.
* Ensure the Stability lab, Stability Suites and storerooms are maintained as a safe and compliant working environment, raising near misses where needed.
* Supporting any other tasks required by the Laboratory Manager/Team Leaders.
Skills & Experience:
* Preferably 2-3 years' experience working in Medical Device/Pharmaceutical Industry within an R&D/product development or quality department role.
* Ability to react and respond positively to changes in priority and workload.
* Competent in following and adhering to pre-determined stability study protocols, SOPs, OCIs and TDs.
* Basic experience in the utilisation of computerised systems to manage data and information.
* Good working knowledge of Microsoft Office - specifically Word and Excel.
* Understanding of compliance with FDA and European Regulations (ICH), Quality Systems and GMP Guidelines.
* Proactive and positive mindset with an attitude that is open to change to embrace new ways of working and improvements.
* Proven experience leading thorough Quality investigations and implementing effective preventative and corrective measures.
Strong communication skills to effectively collaborate cross-functionally.
Qualifications/Education:
* B.Sc. or equivalent in a scientific discipline (e.g., Chemistry, Biology).