Are you looking for an exciting opportunity in the pharmaceutical industry? Fortrea, a global contract research organization (CRO), is hiring for the position of Associate Validator II in Bangalore. This is a full-time position offering a chance to work with a team dedicated to transforming drug and device development worldwide.
About Fortrea
Fortrea is a leading CRO with extensive experience in clinical development. The company provides innovative solutions in clinical trials, patient access, and technology services across more than 100 countries. With a strong focus on scientific rigor and operational excellence, Fortrea is committed to advancing medical research and bringing life-changing therapies to patients.
Job Overview: Associate Validator II
As an Associate Validator II, you will play a crucial role in supporting Global EDC (Electronic Data Capture) Solutions. Your primary responsibility will be managing documentation, ensuring quality control, and assisting in validation tasks. If you have a keen eye for detail and experience in handling study documentation, this could be the perfect role for you!
Key Responsibilities
- Serve as a key member of the project team, ensuring accurate documentation and tracking of study materials.
- Assist project teams with validation tasks as needed.
- Create, produce, print, and track study documentation and controlled documents.
- Develop and execute validation test scripts, ensuring precise documentation of results.
- Maintain high-quality standards and adhere to SOPs, GCP (Good Clinical Practice), and ICH (International Council for Harmonisation) guidelines.
- Prioritize workload efficiently to meet project deadlines.
- Maintain validation metrics and support special projects as assigned.
- Accurately record all work performed and assist in quality management activities.
Required Qualifications & Skills
- Education: Bachelor’s or Master’s degree in Pharma, Science, Life Sciences, or a related field.
- Experience: Prior experience in validation, quality control, or regulatory compliance within the pharmaceutical or clinical research industry.
- Technical Skills: Familiarity with Electronic Data Capture (EDC) systems and regulatory documentation.
- Attention to Detail: Ability to handle and organize large volumes of documentation with accuracy.
- Regulatory Knowledge: Understanding of GCP/ICH guidelines and compliance regulations.
- Communication Skills: Strong verbal and written communication skills to interact effectively with project teams.
