Analytical Chemist (Reviewer)

Job Description

Designation - Senior Executive / Assistant Manager Reviewer (ADL)

• Experience into Analytical development with prior knowledge of documents and data review.
• Candidate is presently working as document / data reviewer and must have good skill of documents to be review for regulatory submission.
• Should have expertise in reviewing raw data including chromatograms (soft data as well as hard copies), lab notebooks, various protocols, reports etc. on line by following ALCOA principle.
• Sound understanding of validation activity and its documentation part of dissolution, assay and RS methods, qualification and validation of Instruments and Equipments, calibrations, recalibration, SOPs, transfer protocols and reports, Method development report, query response etc.
• Need to know about Empower software for data review and should have aware about audit trail system and monitoring of same on periodic basic.
• Strong belief in GLP / GDP and QMS includes review of deviations, incidences, CAPA and change control applicable during validation activity or during study.
• Should be able to guide team members for following GDP, GLP and in QMS.
• Need to know about internal audits and managing compliance part of it.
• Good initiator for implementing or upgrading process or system for effective data review for regulatory submission.
• Good training skills and team player.

Job Location - Andheri East, Mumbai (R&D center)

Experience - 8 to 12 years