#R-252459
nate 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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