Officer/Sr Officer Quality Control | Gufic | Navsari

Job Description

Roles and Responsibilities

• Responsible for Analytical Method Validation.
• Responsible for HPLC/GC instrument handling.
• Responsible for Daily review of Analytical balance and Daily Temperature monitoring.
• Responsible to follow SOP.
• Responsible to follow analytical procedures and generate online raw data.
• Responsible for Stability Studies and Analysis.
• Responsible to operate and analyze of raw materials, In Process, cleaning samples, samples for vendor qualification, Stability samples, standard and Finish product Samples and instrumental method (HPLC / UPLC / GC) and to perform analysis of process validation.
• Responsible for Daily verification of analytical balance and daily temperature monitoring. Online entry in logbooks of instrument, column, working standard, chemical inventory whenever use.
• Responsible for in process data review in night shift.
• Finished product sample receive, entry taken in register and maintain daily status.
• Responsible to follow all the Standard operating procedures, to give Instructions for housekeeping, cleaning and maintaining the laboratory area.
• Responsible to follow all the analytical procedures and generating online raw data, Chromatograms, calculation sheets and charts with reviewer signature.
• Responsible to control and maintain records like protocols, Specification, Standard test procedure, Analytical work record, Standard operation procedure, In- process analysis records, usage log books and status labels during day to day Analysis.
• Responsible to perform calibration and maintain its records.
• Responsible to Prepare and maintain record of finished product.
• Responsible to maintain record of chemicals, glass wares and other lab items of department.
• Responsible for cleaning, maintenance, and daily calibration of specified instruments.
• Responsible to maintain records and qualification of primary standards, reference standards and working standards.
• Responsible for reporting to senior if any abnormality observed during analysis and perform for the out of specification and to investigate the OOS (Out of specification) or OOT (Out of trend)if found and Responsible for maintaining QMS related documents.
• Responsible to follow various EHS (Environment Health and safety) guideline and use appropriate PPEs (Personal protective equipments).

Desired Candidate Profile

• Candidate Should be from a Pharma background
• Candidate Should have excellent knowledge of ICH Guidelines
• Prefer Who can work a shift and is willing to relocate to Navsari, Gujarat
• Candidate should have Work Accuracy.

Qualification: B.Sc, MS/M.Sc(Science) in Organic Chemistry, Chemistry, Bio Chemistry