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.
- 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.
- 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…… click apply for full job details