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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, dedicated to patient-focused solutions.
- Benefits: Enjoy hybrid working options and a supportive work environment with opportunities for growth.
- Why this job: Join a mission-driven company that values diversity and makes a real impact on patients' lives.
- Qualifications: Degree in pharmacy or life science, plus 2-3 years in the pharmaceutical industry required.
- Other info: Experience with MHRA inspections and GxP processes is essential.
The predicted salary is between 36000 - 60000 £ 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 audits and compliance during the interview. Be ready to share specific examples of how you've successfully managed GxP processes or improved compliance in previous roles.
✨Tip Number 4
Showcase your problem-solving skills by thinking of scenarios where you had to overcome challenges related to quality management. This will highlight your ability to handle the responsibilities of the Local Quality Manager role effectively.
We think you need these skills to ace Local Quality Manager UK & Ireland CSL Vifor
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Local Quality Manager position. Make sure you understand the responsibilities and qualifications required, especially regarding GxP compliance and inspection readiness.
Tailor Your CV: Customise your CV to highlight relevant experience in the pharmaceutical industry, particularly any roles involving GxP processes, audits, and compliance. Use specific examples that demonstrate your skills and achievements in these areas.
Craft a Strong Cover Letter: Write a compelling cover letter that connects your background to the role. Emphasise your understanding of the regulatory environment and your experience with MHRA inspections. Show enthusiasm for working with CSL Vifor and their mission.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail, which is crucial for this role.
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 ensured compliance in your previous roles, as this will be crucial for the Local Quality Manager position.
✨Showcase Your Inspection Readiness Experience
Since experience in inspection readiness is required, come equipped with examples of past inspections you've been involved in. Highlight any specific challenges you faced and how you overcame them to ensure a successful outcome.
✨Demonstrate Your 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 clearly illustrate your thought process.
✨Highlight Your Communication Skills
As the role involves collaboration with various teams, emphasise your ability to communicate effectively both orally and in writing. Be ready to provide examples of how you've successfully communicated complex information to different stakeholders.
