Piramal Group has interests in a portfolio of businesses including financial services (Piramal Enterprises Limited), pharmaceuticals (Piramal Pharma Limited), and real estate (Piramal Realty). With operations in 30 countries and brand presence in over 100 markets, the Group’s turnover is ~1.9 billion usd in FY 2022.
Post : Senior Research Associate - AD
Job Description
• 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.
• 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).
• Maintain hygienic condition in laboratory.
• Follow GxP (GMP, GDP, GLP) for all processes.
• Ensuring proper use of Personal Protective Equipment.
• 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.
• Accompany the internal audit and provide appropriate response to audit observations.
• Training on GDP/GLP/DI to the scientist on quarterly basis to ensure compliance.
• Tracking and monitoring of calibration planner and preventive maintenance planner.
Candidate Profile
M.Pharm / MSc. Chemistry
Additional Information
Qualification : M.Pharm / MSc. Chemistry
Location : Ahmedabad, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : AD
End Date : 30th June 2025
See All M.Pharm Alerts B.Pharm Alerts B.Sc Alerts Maharashtra Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
