Job Description:
o Maintain thorough knowledge of GLP requirements, regulatory guidelines, and SGS SOPs.
o Work with SGS Management and the test sites as needed to approve a GLP study plan.
o Create, maintain, and consolidate (from separate distributed phases) a study audits and file that contains all documentation during the course of the study.
o Plan the audits of the study to ensure that all phases of the study are audited.
o Review the raw data Final Report and other study related information.
o Auditing and ensuring the scientific conduct of regulatory studies and the principles of GLP
o Conducting facility, process and study audit in testing lab, TICU and Archives
o Communicating the discrepancies to Study directors and Management
o Experienced in preparation of SOP
o Maintenance of validation status of the instruments
o Maintenance of GLP documents
o Maintain liaison with regulatory agencies in conjunction with: test protocols, and past or present studies submitted for regulatory approval, compliance with GLP's and appropriate test guidelines.
o Any other duties assigned.
o At all times, comply with SGS Code of Integrity and Professional Conduct.
Salary:INR 4,00,000 - 6,00,000 P.A
Industry:Agriculture / Dairy
Farea:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role:Chemical Research Associate/Scientist
Keyskills:Qa ManagementTesting ComplianceValidation Process StudyGLP
Desired Candidate Profile:
Education: UG - B.Sc - Chemistry
PG - M.Sc - Chemistry
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Company Profile:
SGS India Pvt. Ltd.
http://www.sgs.com
SGS is the world's leading inspection, verification, testing and certification company
Contact Details:
Recruiter Name:Megha Kadge
Contact Company:SGS India Pvt Ltd
Reference Id:AGRI-QAMGRGLP
naukri
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