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- Tasks: Ensure quality in pharmaceutical distribution and oversee GxP compliance procedures.
- Company: CSL Vifor is a leader in iron deficiency and nephrology, focused on innovative patient solutions.
- Benefits: Enjoy hybrid working options and a supportive, diverse workplace culture.
- Why this job: Join a mission-driven company that impacts lives and fosters professional growth.
- Qualifications: Degree in pharmacy or life science; 2-3 years in the pharmaceutical industry required.
- Other info: Opportunity to mentor staff and engage in compliance audits.
The predicted salary is between 45000 - 63000 £ per year.
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.
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 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.
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!
Local Quality Manager UK & Ireland CSL Vifor employer: CSL Vifor
Contact Detail:
CSL Vifor Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Local Quality Manager UK & Ireland CSL Vifor
✨Tip Number 1
Familiarise yourself with GxP compliance procedures and regulations specific to the UK and Ireland. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to quality management in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the pharmaceutical sector, especially those who have experience with MHRA inspections. Engaging with industry peers can provide valuable insights and potentially lead to referrals for the Local Quality Manager position.
✨Tip Number 3
Prepare to discuss your experience with conducting and managing audits during the interview. Be ready to share specific examples of how you've ensured compliance and improved processes in previous roles, as this will highlight your suitability for the position.
✨Tip Number 4
Showcase your problem-solving skills by thinking of scenarios where you've had to address compliance issues or improve quality systems. Being able to articulate these experiences will set you apart from other candidates and demonstrate your proactive approach.
We think you need these skills to ace Local Quality Manager UK & Ireland CSL Vifor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in the pharmaceutical industry, particularly focusing on GxP compliance and inspection readiness. Use specific examples that demonstrate your ability to manage audits and maintain quality standards.
Craft a Strong Cover Letter: In your cover letter, express your passion for quality management in pharmaceuticals. Mention your understanding of the regulatory environment and how your skills align with the responsibilities outlined in the job description.
Highlight Relevant Qualifications: Clearly state your degree in pharmacy or life sciences and any additional certifications related to GxP processes. Emphasise your experience with MHRA inspections and your ability to analyse data effectively.
Showcase Problem-Solving Skills: Provide examples in your application that illustrate your problem-solving abilities and attention to detail. This could include situations where you successfully navigated compliance challenges or improved processes within your previous roles.
How to prepare for a job interview at CSL Vifor
✨Understand GxP Compliance
Make sure you have a solid grasp of Good Distribution Practices (GDP) and Good Documentation Practices (GDP). Be prepared to discuss how you've applied these principles in your previous roles, especially in relation to inspection readiness.
✨Showcase Your Audit Experience
Since the role involves conducting and managing audits, be ready to share specific examples of audits you've been involved in. Highlight any challenges you faced and how you overcame them, as well as the outcomes of those audits.
✨Demonstrate Problem-Solving Skills
Prepare to discuss scenarios where you've had to solve complex problems related to quality management. Use the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your analytical abilities.
✨Communicate Clearly
As the role requires clear communication of information, practice articulating your thoughts logically and concisely. You might be asked to explain technical concepts, so ensure you can do this in a way that's easy to understand for non-experts.
