Scientist 2 - Stability
- Connah's Quay, Flintshire Cheshire
- Temporary
- Full-time
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- Job Title: Scientist 2 - Stability
- Contract: 12 months
- Location: Deeside
- Pay: £134 p/d
- 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 company 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.
- Preferably 2-3 years' experience working in Medical Device/Pharmaceutical Industry within an R&D/product development or quality department role.
- Experience in quality and compliance
- 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.