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- Tasks: Lead the management of Quality Events and Corrective Actions, ensuring compliance and timely completion.
- Company: Join PrimeVigilance, a global leader in pharmaceutical quality assurance.
- Benefits: Enjoy training opportunities, a supportive environment, and a diverse workplace culture.
- Why this job: Make a real impact in healthcare while growing your career in a collaborative team.
- Qualifications: A degree in Biomedical or Health Sciences and relevant experience in Quality or Compliance roles.
- Other info: We value diversity and a human-centric approach to work.
The predicted salary is between 36000 - 60000 ÂŁ per year.
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Job Description
The Senior Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and PrimeVigilance requirements.
Job Description
The Senior Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely fashion and are managed in compliance with global regulations, legislation and PrimeVigilance requirements.
Responsibilities
- Lead the administration, tracking and management of QEs and CAPAs at PrimeVigilance
- Co-ordinate root cause investigation meetings and support Subject Matter Experts to conduct efficient root cause analysis
- Lead QEs and CAPAs management through the workflow
- Provide support to operations and act as subject matter expert on process of managing QEs and CAPAs
- Participate and lead in business process optimization and continuous improvement projects / activities
- Exercise oversight over timely completion of action items (CAPA and Effectiveness checks) for QEs raised for US projects
- To participate in audits and inspections to act as a QE and CAPA subject matter expert (SME)
- Provide training and coaching to train the business operations and junior QE and CAPA team members with regards to Quality Management
- Support the line manager for periodic trending of deviations data across the company
- Provide peer review of QE work performed by colleagues
- Respond to audit findings and audit requests
Qualifications
- University degree in Biomedical sciences, Natural sciences or Health Sciences is required
- Relevant experience in a Quality and/or Compliance-related role
- Prior experience in Pharmacovigilance, Medical Information, or Medical Devices
- Experience of using an electronic Quality Management System desirable but not required
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We Offer
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly, supportive working environment
- Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application.
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Quality Assurance
-
Industries
Pharmaceutical Manufacturing
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Senior Quality Officer (QEs and CAPAs) employer: PrimeVigilance
Contact Detail:
PrimeVigilance Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Quality Officer (QEs and CAPAs)
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines related to Quality Events (QEs) and Corrective and Preventative Actions (CAPAs). This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality management.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in quality assurance. Attend relevant conferences or webinars to connect with potential colleagues and learn more about the role and its challenges.
✨Tip Number 3
Prepare to discuss specific examples from your past experience where you've successfully managed QEs or CAPAs. Highlight your problem-solving skills and ability to lead investigations, as these are crucial for the Senior Quality Officer role.
✨Tip Number 4
Showcase your ability to work collaboratively by preparing examples of how you've trained or supported team members in quality management processes. This aligns with our emphasis on teamwork and personal development at StudySmarter.
We think you need these skills to ace Senior Quality Officer (QEs and CAPAs)
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Senior Quality Officer. Familiarise yourself with Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) to demonstrate your knowledge in your application.
Tailor Your CV: Highlight relevant experience in Quality Management, Compliance, or Pharmacovigilance in your CV. Use specific examples that showcase your ability to manage QEs and CAPAs effectively.
Craft a Compelling Cover Letter: Write a cover letter that reflects your passion for quality assurance and your understanding of PrimeVigilance's core values. Mention how your skills align with their emphasis on diversity, collaboration, and continuous improvement.
Showcase Your Qualifications: Clearly state your educational background in Biomedical, Natural, or Health Sciences. If you have experience with electronic Quality Management Systems, be sure to mention it, as it could set you apart from other candidates.
How to prepare for a job interview at PrimeVigilance
✨Understand QEs and CAPAs
Make sure you have a solid grasp of Quality Events (QEs) and Corrective and Preventative Actions (CAPAs). Be prepared to discuss your experience with these processes and how you've managed them in previous roles.
✨Showcase Your Analytical Skills
Since the role involves root cause analysis, be ready to demonstrate your analytical skills. Prepare examples of how you've successfully conducted investigations and resolved quality issues in the past.
✨Familiarise Yourself with Regulations
Brush up on global regulations and legislation related to quality management in the pharmaceutical industry. Being knowledgeable about compliance will show that you're serious about the role and understand its importance.
✨Emphasise Team Collaboration
Highlight your ability to work collaboratively with different teams. Discuss any experiences where you've led or participated in cross-functional projects, as this is crucial for optimising business processes and improving quality management.
