Piramal Pharma Solutions (PPS)
Designation : Senior Research Associate-AD
Function : Research & Development
Functional Area : Analytical Development
Job Role Summary : Review of QMS events, Method Validation, Qualitfication documents, Clinical Batch release and stability data, ensure compliance
Job Profile :
- Thorough review of clinical batch release data, method validation protocol & report, clinical stability sample analysis, as per cGMP and regulatory requirement.
- Ensure review of daily verification/calibration of pH meter, balances and TOC.
- Ensure review of calibration record of all analytical instruments and update of calibration planner in timely manner.
- Thorough review of method development report and investigation study report
- Randomly review and cross verify all analytical instrument logbook entries and laboratory notebook for its completeness for compliance point of view.
- Randomly review of standard, column and chemical management logbooks.
- Ensure in-house compliance system.
- Randomly review of QMS activities (i.e. change control, incident, deviation).
- Thorough review of IQ/OQ and PQ of instrument/equipment.
- Ensure computer System Validation according to CSV SOP and identify gap in qualification document according to CSV SOP.
- Perform internal audit of AD and provide appropriate training to AD team.
- Tracking and monitoring of calibration planner and preventive maintenance planner.
- Prepare trending of Events/Incident and ensure completeness of its closure. Identify the gaps and provide appropriate training to analytical scientist to strengthen compliance level.
Job Requirements :
Experience in Analytical Development, Analytical Validation, Laboratory compliance.
Type of Experience : Pharma Analytical Development, Validation Quality control
Academic Qualifications :
M. Pharm/ M.Sc. Chemistry
