Biocon Biologics is seeking a highly motivated Jr. Clinical Quality & Compliance Specialist to join our Clinical Development and Medical Affairs team. In this role, you will support the continuous improvement of clinical processes and ensure that our clinical trials adhere to the highest quality standards. This is a fantastic opportunity for someone with a background in clinical research to contribute to impactful work in a fast-paced, global environment.
Key Responsibilities:
- Support the development and maintenance of ICH-GCP compliant processes for clinical trials.
- Assist in internal quality audits, CAPA (Corrective and Preventive Actions), and Quality Management Reviews.
- Conduct quality reviews to ensure clinical trials comply with protocols, GCP guidelines, and regulatory requirements.
- Identify non-conformances and provide recommendations for continuous quality improvements.
- Perform internal quality reviews of Trial Master Files and study documents (e.g., Protocols, IBs, ICFs).
- Participate in sponsor quality visits to sites and CROs.
- Support vendor selection and audits to ensure compliance and quality.
- Conduct risk assessments of internal systems and processes.
- Assist in training coordination for the Clinical Development and Medical Affairs teams.
Qualifications:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, MBBS, MD, or related field.
- Minimum of 2+ years of experience in clinical research, preferably within a sponsor organization.
- Strong understanding of clinical trial processes and GCP guidelines.
- Excellent written and verbal communication skills.
- Ability to work collaboratively with internal teams and external stakeholders.
- Willingness to travel for site and vendor reviews as needed.
