Stability Scientist 2

Job Title –Stability Scientist 2

Location – Deeside

Contract Length – 12 months

Pay Rate – £134 per day

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.

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 Convatec 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.