An excellent opportunity has opened up to join the Quality department of a global pharmaceutical facility.

The key responsibilities include butare not limited to:

• Responsible for preparing and reviewing FMECA risk assessments relating to product release for QPs.
• Review and update of medical device product risk assessments as per ISO 14971, e.g. as part of due diligence for new products in-licensed.
• Responsible for preparing and reviewing transportation route temperature excursion risk impact assessments as per Annex 16 (EU cGMP).
• Preparation and / or review of excipient risk assessments.
• Preparation and / or review of facility risk assessments (Chapter 3 and Chapter 5, EU cGMP)
• Creation and maintenance of product groupings based on risk assessments.
• Responsible for keeping and/or monitoring an internal European-wide database of risk assessments
• Keeping abreast of regulatory requirements on quality risk management and acting as an SME for training purposes on QRM for the Group.
• Monitoring o and maintaining access to trending in product and QMS critical parameters.
• Participation in the EU MA Holders' auditing programme, as required

Additional responsibilities for this role

• Responsible for preparing and reviewing FMECA risk assessments relating to product release for QPs.
• Review and update of medical device product risk assessments as per ISO 14971, e.g. as part of due diligence for new products in-licensed.
• Responsible for preparing and reviewing transportation route temperature excursion risk impact assessments as per Annex 16 (EU cGMP).
• Preparation and / or review of excipient risk assessments.
• Preparation and / or review of facility risk assessments (Chapter 3 and Chapter 5, EU cGMP)
• Creation and maintenance of product groupings based on risk assessments.
• Responsible for keeping and/or monitoring an internal European-wide database of risk assessments
• Keeping abreast of regulatory requirements on quality risk management and acting as an SME for training purposes on QRM for the Group.
• Monitoring o and maintaining access to trending in product and QMS critical parameters.
• Participation in the EU MA Holders' auditing programme, as required

Key requirements for this role:

• 5-8 years' experience in a pharmaceutical or medical device manufacturing QA environment preferably with experience in risk assessment.
• Hands-on experience working in an MA or CE Mark Holder's QA or Design / Development QA Department.
• Knowledge of statistics and mathematical probability
• ISO 13485 and ISO 14971
• Project management experience

If this role appeals to you and seems like it could be a good fit please don't hesitate to apply!