At a Glance
- 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.
- Other info: We value diversity and a human-centric approach to work.
- 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.
The predicted salary is between 36000 - 60000 £ 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
As a PV Officer, Team Lead, you will thrive in a dynamic and supportive environment that prioritises personal and professional growth. Our company offers extensive training and development opportunities, fostering a culture of collaboration with colleagues from around the globe, all while ensuring effective ICSR management. Join us to make a meaningful impact in pharmacovigilance while enjoying a friendly workplace that values your contributions.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Quality Officer (QEs and CAPAs)
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like PrimeVigilance. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like PrimeVigilance.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what PrimeVigilance is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Senior Quality Officer (QEs and CAPAs)
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at PrimeVigilance!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show PrimeVigilance that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at PrimeVigilance!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At PrimeVigilance, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at PrimeVigilance
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at PrimeVigilance that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with PrimeVigilance’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
