QA Specialist - 6 month contract

An excellent opportunity has arisen for a QA Specialist to join a leading global Pharmaceutical company based in Hertfordshire on an initial 6 month contract.



Job Purpose:



  • Implement the controlled document strategy for PDQ and the supported business partners (PD, GPS and Affiliates) for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.

  • To develop Global Procedural Documents, e.g., Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs)from identification of needs, to execution of development and deployment of outputs and materials.



Primary Responsibilities and Accountabilities:



  • Supports establishment of GxP Global Procedural Documents throughout all of the client related organizational enterprises (PD, GPS and Affiliates) to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations.

  • Builds and maintains strong relationships with key business stakeholders and ensures that PDQ is providing an efficient, effective and compliant process landscape to the functions.

  • In close collaboration with supported functional areas and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement.

  • Ensures that business partner expectations for Procedural Document strategy, materials and deployment are met.

  • Ensures, in collaboration with business partners, that Global Procedural Documents in the GxP process landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations.

  • Collaborates with a network of subject matter experts (SMEs) across the functional areas, supporting the Global Procedural Documents development.

  • Contributes to the PDQS Standards, Systems & Processes Governance Team to set strategies and achieve the long-term goals and objectives of PDQS and PDQ as a whole.

  • Is knowledgeable of all services and activities provided by PDQS, Standards, Systems and Processes Governance in order to provide business stakeholders with a comprehensive overview and effectively communicates this to stakeholders.

  • Supports internal process improvement projects.



Education/Qualifications:



  • Bachelor's degree or equivalent in scientific or quality-related field or equivalent combination of education, training, and experience.

  • 3-5 years in the pharmaceutical industry, preferably in pharmaceutical development and working in a GxP regulated area.

  • Experience in preparation, development and administration of GxP standards and processes.

  • Organizational awareness (e.g., interrelationship of departments, business priorities), including experience successfully working cross-functionally and in global teams.



For further details about this role, or other roles within QA, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk



  • Start: asap
  • Rate: £250.00 - £300.00 per day
  • Location: St. Albans, England
  • Type: Contract
  • Industry: Pharmaceutical
  • Recruiter: Key People
  • Tel: +44 (0)1727 817 626
  • Fax: 01727 844 838
  • Email: to view click here
  • Posted: 2020-09-10 17:38:35 -

  • View all Jobs from Key People


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