Contract QP opportunity Glasgow
|Job Title:||Contract QP opportunity Glasgow|
|Contact Name:||Nathan Wilson|
|Job Published:||July 20, 2017 16:43|
Primary Job Function
The primary job function of the Contract QP is to discharge the legal and routine responsibilities of the QP and Annex 16 of the EU GMP Guide.
Job specific responsibilities:
The post holder will:
- Perform Batch Certification of IMPs.
- Provide on-site and/or on-call cover in conjunction with internal QP or other contract QPs to ensure continuous QP availability.
- Liaise with other QPs to review prospective availability and required periods of cover.
- Provide general GMP compliance oversight and advice for manufacturing and QC testing activities.
- Where possible attend (in person or by conference call) Quality Review meetings.
- Participate in internal / external audits as required.
- Assist with provision of GMP and Specials training where required.
- Highlight in writing to Operational and QA management where necessary if standards are deemed to fall short of the requirements for EU Good Manufacturing Practice.
- Provide subject matter expert on the development of new systems/testing and maintenance.
- Perform batch release of unlicensed medicinal products.
- Perform Batch Release of 'Specials' produced for use under the terms of Manufacturer's Specials Licence in compliance with the order.
- Be present on-site as requested during regulatory inspections from MHRA or other relevant regulatory authorities while named on Manufacturing Authorisation(s).
- Provide input as required into GMP Continuous Improvement Projects.
- Stay abreast of developments in Regulatory Guidance as they apply to GMP, and ensure relevant Operational and Quality Management are informed of significant changes.
- Provide training to Quality Personnel (i.e. batch review and Product specification).
- Pharmaceutical Biotechnology experience including cell culture technology required
- Experience in release of ATMPs desirable
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