Senior Quality Officer (QEs and CAPAs)

PrimeVigilance; Greater London; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading company in pharmaceuticals is looking for a Senior Quality Management Officer to ensure timely management of Quality Events and Corrective Actions in compliance with regulations. The role involves oversight of operations, participation in audits, and providing training to the team, fostering a culture of quality improvement within the organization.

Benefits

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly, supportive working environment

Global collaboration

Qualifications

• University degree in relevant field required.
• Experience in Quality and/or Compliance-related role desired.
• Prior experience in Pharmacovigilance, Medical Information, or Medical Devices is beneficial.

Responsibilities

• Lead administration, tracking and management of Quality Events and CAPAs.
• Coordinate investigations and lead root cause analysis.
• Ensure compliance with global regulations and provide training for junior team members.

Skills

Leadership

Communication

Analytical skills

Root cause analysis

Compliance knowledge

Education

University degree in Biomedical sciences, Natural sciences or Health Sciences

Job description

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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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