Local Quality Manager UK Ireland CSL Vifor
Local Quality Manager UK Ireland CSL Vifor
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Salary Not Disclosed
1 Vacancy
Job Description
As the Local Quality Manager for UK and Ireland within the CSL Vifor function you will be responsible for ensuring the quality for the distribution of pharmaceutical products by CSL Vifor and partners in the UK and Ireland. In this role you report directly to the CSL Vifor Lead Quality Affiliate & Partners West. The role is office based with Hybrid working. You will collaborate with the local safety office medical affairs distributor and vendors. Experience in Inspection readiness will be required for this role. Hybrid/flexible working offered.
Responsibilities include:
- To oversee all GxP compliance procedures related to GxP legislation and monitor adherence from a QA perspective
- To ensure that all relevant activities and materials produced by VPUK are in accordance with Vifor Pharma SOPs policies guidelines and procedures and relevant local legislation
- Coordinate and manage the system for maintaining procedures /processes
- Develop manage and maintain tracking records and filing systems
- To monitor and processes to ensure effective business objectives are met whilst maintaining and improving GxP compliance
- To coordinate the preparation and for external and internal GxP (Good Distribution Practices and Good Documentation Practices) Compliance audits
- Train and mentor VPUK staff members in relation to GxP procedures as required.
- Overseeing the review update and maintenance of regulatory documents in accordance with SOPs and local legislations including product licenses.
- Undertake internal compliance audits of procedures related to GxP
- Maintain tracking electronic and hard copy filing of supplier contracts/agreements etc.
- Assist in the drafting and checking of quality agreements
Qualifications Skills and Competencies
- Degree in pharmacy or life science or equivalent.
- Experience with MHRA inspections
- 23 years experience in the pharmaceutical industry or other relevant experience.
- Understanding of pharmacovigilance systems and the regulatory environment.
- Knowledge of and involvement in GxP (Good Distribution Practices and Good Documentation Practices) processes
- Experience of conducting and managing audits
- Ability to analyse data and communicate information clearly and logically both orally and in written form.
- Ability to prioritise
- High standards and attention to detail.
- Effective problemsolving skills.
- Ability to work selfsufficiently and overview multiple tasks.
About CSL Vifor
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patientfocused solutions across iron dialysis nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe chronic and rare diseases lead better healthier lives. It specializes in strategic global partnering inlicensing and developing manufacturing and marketing pharmaceutical products for precision patient care.
For more information please visit viforpharma
We want CSL to reflect the world around us
As a global organization with employees in 35 countries CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Vifor!
Required Experience:
Manager
Employment Type
Full-Time
