Functional Quality Specialist Job at Fortrea | Apply now for a Hybrid Role in Pune
Looking to advance your career with high-impact Pharma Jobs? This Functional Quality Specialist Job offers a hybrid work model in Pune for professionals experienced in pharmacovigilance and quality review. If you are seeking growth in regulatory safety, client quality audits, and CAPA implementation, this Pharma Jobs opportunity with Fortrea can take your career to the next level.
- Job Title: Functional Quality Specialist I
- Locations: Pune
- Job Requisition ID: 26444
About the Company
Fortrea is a global contract research organisation (CRO) providing end-to-end clinical development, pharmacovigilance, and regulatory services. Known for quality-driven delivery and compliance excellence, Fortrea offers rewarding Pharma Jobs for professionals looking to build careers in global drug safety and quality management.
Job Description
The Functional Quality Specialist Job is responsible for providing all clients, both internal and external, with the appropriate quality of service safely and cost-effectively. The post holder will comply with legal requirements of the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as documented in the Company’s Health and Safety Manual. This Pharma Jobs opportunity involves quality review, safety documentation, audit readiness, and regulatory compliance for global clients.
Key Responsibilities
- Perform a quality review of assigned cases.
- Assist in compiling quality metrics and identifying quality trends.
- Assist in addressing periodic client quality reviews.
- Assist in the preparation and implementation of Corrective and Preventive Actions (CAPA).
- Perform ongoing review of safety reports, labelling, and regulatory documents.
- Manage and review expedited adverse events, product quality complaints, and medical information.
- Assist in process review, audit readiness, and regulatory inspections.
- Design and track training schedules and materials.
- Contribute to quality forums and process improvement initiatives.
- Execute drug safety data management processes, including case follow-up and documentation.
- Review medical information queries and product quality complaints.
- Support the sponsor during regulatory inspections or audits.
- Perform analysis of data and drive strategies for process improvement.
- All other duties as assigned.
Qualifications
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Bachelor’s/Master’s/PhD degree in Medicine or Alternative medicine, Medical Science, Pharmaceutical science, Nursing, Life Sciences, Biological Sciences, or related area.
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Fortrea may consider relevant and equivalent experience instead of educational requirements.
Experience
- Two plus years of overall experience in the pharmaceutical industry, biotechnology, or CRO industry, primarily in Pharmacovigilance / Safety writing, with some experience in Peer review / Quality review.
- Knowledge of GCP, GVP, ICH Guidelines, EU and FDA regulatory requirements.
- Knowledge of worldwide adverse event reporting.
- In-depth understanding of case processing and assessment.
- Technical proficiency with Microsoft Office applications.
Preferred:
- Experience in quality metrics, trend analysis, and CAPA reports.
- Knowledge of Medical Device reporting is desirable.
