A global pharmaceutical company is currently looking for a Quality Assurance Senior Specialist to join their team based in Buckinghamshire, UK.
Working as a Quality Assurance Senior Specialist, you will be responsible for the planning and conduct of audits of the clinical research activities of the company, Pharmacovigilance audits, business partners and vendors, through to the critical evaluation of documents, procedures and facilities. The audits provide an independent quality assessment to assure compliance with appropriate regulations and company SOPs and processes. Previous experience in compliance is required (GPVP, GCP and IT Validation)
The successful candidate for this Quality Assurance Senior Specialist job will be educated to Bachelor of Science (BSc) degree level in a life science, natural science or computer science with experience in a specific compliance area and/or equivalent time and experience in a related R&D area.
This Quality Assurance Senior Specialist job also demands a candidate with the following skills, competencies and experience:
- Be highly motivated to work effectively either independently or as an active member of a global team. Will prepare and effectively communicate audit report findings to colleagues and stakeholders.
- Have a detailed knowledge and background in Good Clinical Practice (GCP), Pharmacovigilance (PV), or Information Technology (IT) systems compliance.
- Contribute to the assessment of current quality of clinical & PV systems and make recommendations for improvement. Assist in process improvements and ongoing development of new auditing procedures, techniques and department guidelines.
- Interact with internal/external appropriate functional personnel in order to identify issues and recommend actions identified throughout the audit process.
- Comprehensive knowledge in specific compliance discipline (GLP, GMP, GCP, GPvP or IT Validation)
- Comprehensive knowledge of the drug development process, regulation awareness and scientific terminology.
- Understand pre-clinical/clinical systems or computer systems compliance documentation and regulatory records.
- Knowledge of SOPs and documentation requirements in a regulated industry.
- Good oral and written communication skills, organized, detail oriented.
- The successful candidate will have good direct QA or functionally related experience, or equivalent training.
How to Apply
For more information, or to apply for this Quality Assurance Senior Specialist job, please contact Hendre at CK Clinical on tel: +44 (0)1438 870 023 or email me at firstname.lastname@example.org quoting 19686 to indicate your interest.
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