BPharm, BSc, MPharm, MSc, MBBS, BAMS; Experience in PV/ Clinical Research drug safety preferred. Ability to understand and analyses the complex data and performs the activities including accessing the case in Argus, code and enter data.
Expertise in designing, executing, and reviewing cleaning validation protocols. ensuring compliance with cGMP. EMA. and other global regulatory requirements. Specializing in stability studies, regulatory compliance, and quality assurance oversight. Managing stability programs in alignment with ICH guidelines
As part of our team, you'll be responsible for a diverse range of tasks within the drug discovery process. In this role, you will have ample opportunities to collaborate with our dynamic team, providing scientific expertise and strategic leadership.
Hands-on experience with HPLC, GC, UV-Visible Spectroscopy and Dissolution tester. Proficient in Empower-3 software.
Strong analytical and problem- solving skills.
The Clinical Data Management Associate is responsible for providing expert skills as part of the clinical data management team within the Data Management and Statistics Department to ensure that efficient and quality data management products are produced in accordance with customer requirements.
Ensure that Bulk Viral Antigen production adheres to GMP standards on the shop floor, including line clearance, dispensing, and preparation processes. Examining and approving batch records, standard operating procedures, project plans, customer verification, and APS documents.
To be an integral part of an antibody development team with a focus on performance and improve customer outcomes through validation of cell culture workflows, reagents, and consumables.
SCIENCES OR PHARMACY GRADUATES B.SC, M.SC, B. PHARM, M. PHARM WITH 0 TO 5 YEARS EXPERIENCES IN PARENTERAL MANUFACTURING VIAL, AMPOULES, BOTTLES OF GLASS OR PLASTIC THROUGH, LVP/SVP WITH BFS TECHNOLOGY. CANDIDATE WORKED IN PRODUCTION COMPLIANCES, REMEDIATION AND HAVING EXPERIENCES OF MANAGING QUALITY SYSTEM DOCUMENT