Quality Assurace Manager GDP

England  ‐ Vor Ort
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Beschreibung

A global pharmaceutical company is looking for a quality assurance manager to join their team and take charge for GDP related task in the UK.
Principal Responsibilities
  • ensure the roll out and on-going compliance to the global quality and compliance systems, and associated procedures and standards to the responsible cluster.
  • Provide leadership and resource management support to Corporate Quality and the designated Affiliate
  • Ensure that Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with US, EMA, other global and local GDP, GXP and PV guidelines.
  • Provide internal auditing resource to assess cluster compliance on a regular basis
  • Manage the review and implementation of Quality Improvement/remediation plans for the Affiliate identified through Corporate as well as internal GDP/GXP/PV audits.
  • Monitor GDP, GXP and Pharmacovigilance compliance to regulations and internal procedures and communicate CAPAs and action plans to Country Management and Corporate Quality
  • Act as the Responsible Person (RP) named on the UK Wholesale Dealers Authorisation (WDA) and ensure that the provisions of the licence are observed in accordance with the EU Guidelines on Good Distribution Practice of Medical Product for Human Use (2013/C 343/01)
  • Ensuring that any additional requirements imposed on certain products by national law are adhered to.


Qualifications
  • 5+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
  • Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
  • Strong leadership ability.
  • Good knowledge of government regulations and guidelines ( local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
  • Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
  • Exceptional communication and interpersonal skills
  • Ability to work globally in a matrix environment
  • Ability to influence senior management, peers and other colleagues without direct reporting lines
  • Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs


In order to apply, please send your CV

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
Start
11/2019
Dauer
permanent
Von
Michael Bailey Associates
Eingestellt
13.11.2019
Projekt-ID:
1847538
Vertragsart
Festanstellung
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