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Last Name*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Distribution Practice (GDP)

Location: United Kingdom

Proclinical is seeking a highly motivated individual to join the Quality Assurance team as a Senior Manager, Quality GDP. This UK based role will ensure that products are distributed safely.

Job Responsibilities

Provide leadership and resource management support to Corporate Quality and the designated Affiliate
Ensure that Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, and local PV guidelines
Coordinate Self-inspections and internal auditing resource to assess site compliance on a regular basis. Perform self-inspections
Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GxP audits
In collaboration with the Corporate Quality organization, weigh and communicate quality and compliance risks as appropriate
Act as Quality liaison between the local operational groups and Corporate Quality for GDP/GXP/PV functions and activities.
Partner with local, regional and global operational groups to foster a proactive approach to compliance.
Approve any subcontracted activities which may impact on GDP
Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place

Skills and Requirements

Bachelor's Degree in physical /life science or pharmacy; Advanced degree preferable Compliance and management experience in pharmaceutical/ biotech industry.
Eligible to act as Responsible Person named on the UK Wholesale Dealers Authorisation (WDA)
Thorough knowledge of applicable local and global regulatory requirements required for GDP, GXP compliance.
Good knowledge of government regulations, laws and guidelines pertaining to GXP and Pharmacovigilance required
Experience in using computerized system for Change Control, Deviation and CAPA management Education

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101 or upload your CV on our website - www.proclinical.com/send-cv

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