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 execution 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
* 2-3 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 problem-solving skills.
* Ability to work self-sufficiently 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 patient-focused 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, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
For more information, please visit viforpharma.com
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