Fortrea Hiring Experienced Pharma Professionals for Quality Assurance Job
Looking for a Quality Assurance Job with a globally recognised CRO? Fortrea Careers brings an exciting opportunity for experienced professionals through the Functional Quality Specialist II position in Pune and Mumbai. This role is ideal for candidates with expertise in Pharmacovigilance, Safety Writing, Quality Review, and Regulatory Compliance who are looking to advance their careers in the pharmaceutical and biotechnology industry.
- Job Title: Functional Quality Specialist II
- Job ID: 262647
- Locations: Pune, Mumbai
About the Company
Fortrea is a leading global contract research organisation (CRO) dedicated to advancing clinical development and patient outcomes. The company provides comprehensive drug development and patient access solutions to pharmaceutical, biotechnology, and medical device customers worldwide.
Job Description
- Ensure high-quality service for both internal and external clients.
- Deliver work in a safe, efficient, and cost-effective manner.
- Follow company quality and safety standards at all times.
- Comply with Health and Safety regulations and company policies.
- Maintain adherence to applicable regulatory and compliance requirements.
- Support a safe working environment while meeting project and client expectations.
Key Responsibilities
- Conduct quality reviews and ensure compliance across assigned projects.
- Monitor quality metrics and identify trends for continuous improvement.
- Support client quality reviews and address quality-related findings.
- Prepare and track Corrective and Preventive Actions (CAPAs).
- Review safety reports and regulatory documents for accuracy and compliance.
- Support quality operations related to adverse event and drug safety processes.
- Review adverse events, product quality complaints, and medical information cases within required timelines.
- Ensure closure of CAPAs and maintain supporting documentation.
- Contribute to process improvement initiatives and quality standards development.
- Assist in preparing training schedules and materials for team members.
- Promote best practices and quality awareness across projects.
- Support internal, client, and external audits.
- Assist in drafting Quality Management Plans and inspection readiness activities.
- Ensure compliance with SOPs, regulatory requirements, and project timelines.
- Review medical information queries received through calls, emails, and other communication channels.
- Execute drug safety data management and case follow-up activities.
- Guide safety associates when required.
- Support quality control, data reconciliation, reporting, and training activities.
- Analyse quality data and recommend process improvement strategies.
- Perform additional duties as assigned
Qualifications
- Bachelor’s/Master’s/PhD degree in Pharmaceutical Science or related area.
- Fortrea may consider relevant and equivalent experience instead of educational requirements.
Experience
- Minimum 3 years of experience in the Pharmaceutical, Biotechnology, or CRO industry.
- Experience in Pharmacovigilance or Safety Writing is required.
- At least 1 year of experience in Peer Review or Quality Review.
- Strong knowledge of GPV regulations and EU/FDA regulatory guidelines.
- Good understanding of case processing and case assessment.
- Knowledge of Quality Assurance principles and practices.
- Awareness of Lean methodology concepts for process improvement.
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, etc.).
Preferred Qualifications Include
- Experience in generating quality metrics with trend analysis, authoring, and coordinating Corrective and Preventive Action Reports is preferred.
- Experience in assessing the quality of a case/safety report from a medical, scientific and documentation perspective is preferred.
