Operational Quality Officer
Operational Quality Officer
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Job Description
The Operational Quality Officer is responsible for ensuring departmental quality activities are completed on time following detailed investigations to a high level of quality. The role will be responsible for departmental management of nonconformities deviation corrective and preventive actions and audit and inspection responses. In addition this role will drive quality and compliance by ensuring completion of key quality tasks and ensuring they are managed in compliance with global regulations legislation and PrimeVigilance requirements.
Role and Responsibilities
- Responsible for the deviations and CAPAs in their department working with SMEs
- Supports Subject Matter Experts to conduct root cause analysis or deviations and CAPAs
- Ensures timely completion of actions
- Acts as point of contact for delivery of audit and inspection CAPA preparation and delivery of actions within agreed timelines
- Drives audit and inspection readiness within their department
- Reviews data to drive continuous improvement and excellence in quality.
- Delivers proactive department specific audit and inspection readiness training
- Works with department SMEs to arrange targeted interview practice
- Contributes to development of training material for departmental quality
- Ensures delivery of data required for quality and compliance metrics
- Works closely with quality counterparts and head of department to drive improvement of departmental quality
Qualifications :
- University degree in Biomedical sciences or relevant experience.
- Experience with Pharmacovigilance/MI experience is required
- Prior experience in a Quality and/or Compliance role is required
- Problem Solving skills approaching issues independently and using ones own initiative is necessary
Special Skills
Experience of using an electronic Quality Management System desirable
Language skills
Fluent in verbal and written English
Additional Information :
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a humancentric 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.
Our Offer
- Competitive salary
- Dynamic team of colleagues in a fastgrowing company possibility for your quick career growth
- Multicultural environment English as a company language
- Strong emphasis on personal and professional growth
- Extensive and specialized trainings in pharmacovigilance internal trainings provided by skilled professionals but also prestigious trainings/seminars taking place abroad
- Friendly working environment with several social events per year
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.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
