Requirement of Manager - QA @ Piramal Healthcare Ltd.
Piramal Life Sciences Limited (PLSL) is an independent research-driven drug company that was recently demerged from Piramal Healthcare Limited (Formerly known as Nicholas Piramal India Limited). PLSL was formerly the NCE R&D division of NPIL. PLSL has state-of-the-art R&D laboratories built over 200,000 square-feet of space in Mumbai, India and over 300 scientists engaged in drug discovery and development.
Post: Manager - QA
Job Description:
• To schedule and conduct independent audits for clinical and bioanalytical operations
• To facilitate preparation and revision of SOPs as well as SOP training
• To approve all SOPs for adequacy and GCP/GLP compliance
• To prepare and submit periodic status reports to the Vice-President / Head-Operations listing problem areas and seeking corrective actions during management review meetings
• To impart training on quality assurance principles and auditing procedures to new and existing personnel
• To recommend measures to ensure GCP/GLP compliance
• To maintain copies of approved protocols for all studies conducted in the facility
• To audit each biostudy at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic audit showing the date of audit, the study audited, the phase or segment of study inspected, findings and problems, and any scheduled date of re-audit
• To determine that no deviations from approved protocols or standard operating procedures are made without prior authorization and documentation
• To review the final biostudy reports to assure that such reports accurately describe the methods and SOPs and that the reported results accurately reflect the raw data of the conducted biostudy
• To prepare and sign a authentication statement to be included with the final report which shall specify the audit date and findings reported to Principal Investigator and Study Director
• To host sponsor audits and regulatory inspections.
• To conduct facility audits and submit the audit report.
• To execute any other duties as assigned by Head-Operations.
Desired Profile:
M.Pharm with relevant expereince of CROworking in quality assurance with sound knowledge of GCP/GLP. Must have handled the team.
Additional Information:
Experience: 4-6 Years
Location: Mumbai
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 5th Nov., 2011
Apply/Forward Your Resume at, research.recruitment@piramal.com
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