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Risk & Supplier Quality Manager

Risk & Supplier Quality Manager

Job Title: Risk & Supplier Quality Manager
Contract Type: Permanent
Location: Watford, Hertfordshire
Industry:
Salary: £60000 - £65000 per annum
Start Date: ASAP
Reference: HQ00052405_1487770417
Contact Name: Rachel Radford
Contact Email: r.radford@sciproglobal.com
Job Published: February 22, 2017 13:33

Job Description

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!

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