Location
Mumbai | India
Job description
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Responsibility for product quality related activities with a specific expertise in stability including protocol and report generation.
Supporting the work of Product Quality Integrator (PQI)/ Product Quality Owner (PQO) Managers, Senior Managers and
Directors and actively contributing to overall smooth functioning of the PQM team.
- Attend scheduled meetings
???? Performs stability assessments
???? Timely Issue/Review/Approve Change Controls (CC) and Change Requests
???? Issue/Review/Approve stability monitoring protocols/ stability development protocols
???? Review/Approve stability monitoring reports/ stability development reports
- Compliance with the Good Manufacturing Process (GMP), Environmental Health and Safety (EHS) and Health Authority (HA)
requirements and guidelines, as applicable
- Carries out supportive stability management activities: commentary and finalization of reports, data interpretation, providing
specific technical knowledge and skills.
- Communicates with product data team to ensure that draft reports and other inputs are received in time and in satisfactory
quality. Accountable for ensuring that reports and protocols are ready for approval
- Coordinates work with the with PQIs and PQOs
- Participate in escalations, CCs and project meetings, among others
- Ensure deliverables are submitted on a timely manner
- Manage stability tasks and activities of the assigned products portfolio
- Evaluates stability data and makes qualified judgements and recommendations on reports and data tables
- Provides stability information to facilitate decision making by PQIs and PQOs.
- Timely delivery of stability information
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit
Fortrea is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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