QA Specialist - 6 month contract

Employer
Key People Limited
Location
Homeworking
Salary
£250.00 - £300.00 per day
Closing date
17 Sep 2020
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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

International recruitment solutions

Key People is a truly international operation with offices in the UK, Switzerland and Iraq

We have developed working relationships with many of the FTSE 100 companies, including some of the world's most recognised global brands in the pharmaceutical, Oil, Gas, Energy and engineering industries.

Our dedication to both employers and candidates, and our vast experience enables us to provide superior solutions and effective results. We're proud to be a private company driven by our commitment to our customers and we are constantly exploring new markets in our bid to become the number one recruitment agency for customer satisfaction across a number of industry sectors.

Contact Us
  • Catherine House
  • Adelaide Street
  • St Albans
  • AL3 5BA
  • GB
  • +44 (0) 1727 811634
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