Senior Quality Officer (QEs and CAPAs), Guildford
Location: Guildford, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 6ff1845e5010
Job Views: 4
Posted: 02.05.2025
Expiry Date: 16.06.2025
Job Description
The Senior Quality Management Officer is responsible for ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed accurately and timely, and are managed in compliance with global regulations, legislation, and PrimeVigilance requirements.
Responsibilities
1. Lead the administration, tracking, and management of QEs and CAPAs at PrimeVigilance.
2. Coordinate root cause investigation meetings and support Subject Matter Experts in conducting efficient root cause analysis.
3. Manage QEs and CAPAs through their workflow.
4. Support operations and serve as a subject matter expert on managing QEs and CAPAs.
5. Participate in and lead business process optimization and continuous improvement projects.
6. Oversee the timely completion of action items (CAPA and Effectiveness checks) for US project QEs.
7. Participate in audits and inspections as a QE and CAPA SME.
8. Provide training and coaching to business operations and junior QE and CAPA team members.
9. Assist in periodic trending of deviations data across the company.
10. Peer review QE work performed by colleagues.
11. Respond to audit findings and requests.
Qualifications
* University degree in Biomedical Sciences, Natural Sciences, or Health Sciences.
* Relevant experience in a Quality and/or Compliance-related role.
* Experience in Pharmacovigilance, Medical Information, or Medical Devices.
* Experience with electronic Quality Management Systems is desirable but not required.
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where individuals of all backgrounds can contribute and grow.
We believe in a human-first approach, valuing our people as our greatest strength to improve lives.
We offer:
* Internal training and career development opportunities.
* Focus on personal and professional growth.
* A friendly, supportive work environment.
* Opportunity to collaborate with colleagues worldwide, with English as the company language.
Our core values include:
* Quality
* Integrity & Trust
* Drive & Passion
* Agility & Responsiveness
* Belonging
* Collaborative Partnerships
We look forward to receiving your application.
#J-18808-Ljbffr