Senior Quality Officer (QEs and CAPAs)

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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 levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesPharmaceutical Manufacturing

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