Officer/Sr Officer/Executive/Sr Executive – Quality Control | Gufic | Navsari

Job Description

Roles and Responsibilities:

• Responsible for sampling of raw material and FP (Placebo) for method validation Activity.
• Responsible to perform analysis of analytical method Validation, Analytical method Transfer, reconstitute Solution stability, additional analytical test required as per party quarry reply.
• Responsible for preparation Analytical method validation protocol, raw data, report.
• Responsible for review of Analytical method validation protocol, raw data, report.
• Responsible for preparation excel sheet preparation of analytical method validation, method transfer, Reconstitute Solution Stability Study.
• Responsible for review of method Validation and method transfer protocol and report for Technology Transfer Activity.
• Responsible for planning of method validation activity. Requirement of sample, Standard, reference standard, column, instrument provide to the analyst.
• Responsible for training to the analyst for validation activity.
• Responsible for training providing to the analyst for analytical method validation and method transfer SOPs.
• Responsible to control and maintain records like protocols, raw data and report of method validation, method transfer and reconstitute solution stability. Analysis records, usage log books and status labels during day-to-day Analysis of validation.
• Responsible to follow all the SOPs, to give Instruction for housekeeping, cleaning and maintaining the laboratory area.
• Responsible to follow all the analytical procedures and generates online raw data, Chromatograms, calculation sheets and charts with reviewer signature.
• Responsible to perform calibration and maintain its records.
• Responsible to prepare and maintain record of Analytical method validation, Analytical method transfer.
• Responsible to Prepare and maintain records of photostbility chamber.
• Responsible to Prepare photostability study protocol, raw data and report.
• Responsible to review Photostability data approval, maintain cleaning log.
• 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 of Impurity standards, reference standards and working standards for validation activity.
• Responsible to coordinate with party if any concern.
• Responsible for reporting to senior if any abnormality observed during analysis and perform for the out of specification.
• Responsible to follow various EHS guideline and use appropriate PPEs.
• Responsible for maintaining QMS related documents.

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