6 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.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 PrimeVigilanceCo-ordinate root cause investigation meetings and support Subject Matter Experts to conduct efficient root cause analysisLead QEs and CAPAs management through the workflowProvide support to operations and act as subject matter expert on process of managing QEs and CAPAsParticipate and lead in business process optimization and continuous improvement projects / activitiesExercise oversight over timely completion of action items (CAPA and Effectiveness checks) for QEs raised for US projectsTo 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 ManagementSupport the line manager for periodic trending of deviations data across the companyProvide peer review of QE work performed by colleaguesRespond to audit findings and audit requests

Qualifications

University degree in Biomedical sciences, Natural sciences or Health Sciences is requiredRelevant experience in a Quality and/or Compliance-related rolePrior experience in Pharmacovigilance, Medical Information, or Medical DevicesExperience 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 internallyStrong emphasis on personal and professional growthFriendly, supportive working environmentOpportunity 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!

QualityIntegrity and TrustDrive and PassionAgility and ResponsivenessBelongingCollaborative Partnerships

We look forward to welcoming your application.Seniority level

Seniority level Mid-Senior levelEmployment type

Employment type Full-timeJob function

Job function Quality AssuranceIndustries Pharmaceutical ManufacturingReferrals increase your chances of interviewing at PrimeVigilance by 2xSign in to set job alerts for “Quality Officer” roles.

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