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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) in London 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.
