Global Quality Assurance Manager
1 day ago
About Parkside Recruitment
We are working with a well-established pharma company based in Berkshire to find an experienced Senior Manager, Global Quality Management. This is a fantastic opportunity for you to take on a challenging role and contribute to the success of their global quality management team.
Salary: The salary for this role is around £80,000 per annum, plus a competitive car allowance and bonus scheme.
Job Description:
The main responsibility of this position is to manage and perform audits with a focus on Computer System Validation (CSV) audits. You will work closely with the Head of Global Quality Management, Senior Director Global Quality Management, and the CSV Audit Lead to ensure the development, implementation, and continuous improvement of the company's quality system. Your key accountabilities will include supporting inspections, audits, regulatory intelligence activities, SOP and WP management, and project liaison activities.
Required Skills and Qualifications:
To be successful in this role, you will need a degree in natural science or equivalent business experience. You should have several years of experience in the IT industry, pharmaceutical industry, or relevant regulatory authority experience, preferably including quality assurance for manufacturing, pharmacovigilance, and clinical development, as well as computerised system validation and data integrity. Expert knowledge of relevant regulations and guidance documents, such as computerised system validation, data integrity, manufacturing, pharmacovigilance, clinical development, medical devices, and IMP management, is essential. Additionally, experience as a lead auditor on internal audits and external vendor audits, GxP related CSV audits and inspections, and knowledge and understanding of computerised systems in the GxP environment are highly desirable. Understanding of computer hardware and network/infrastructure requirements is also necessary.
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