Senior Executive / Assistant Manager - ADL

JobItUs

Ahmedabad District

On-site

INR 600,000 - 900,000

Full time

3 days ago

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Job summary

JobItUs in Gujarat, India is seeking an analytical scientist to review method validation, verification, transfer protocols, and related data, while guiding team members in developing cost-effective analytical methods.

The role requires overseeing instrument maintenance, GMP/GLP compliance, safety procedures, and timely project execution with adherence to SOPs and regulatory requirements.

Responsibilities

Review of Analytical Method Validation, Verification, Vendor Qualification, Cleaning validation and Method transfer protocols and reports.
Review of method development and routine stability analysis data.
Review of certificate of analysis and stability data sheet.
To guide team member for development of novel and cost-effective analytical methods.
To perform all type of analysis like Method validation, method verification, method transfer, stability analysis and regulatory query support related work and its documentation as and when required.
To perform and review maintenance and calibration of analytical instruments and its documentation.
To ensure that appropriate safety procedures are followed in the laboratory.
To verify the Contract Giver analytical methods and execute the project scope within the stipulated time frame.
Review of SOP, Specification, Standard test procedure and worksheets as and when required.
To provide on the job training and on advance topics as and when required.
Preparation and Review of Standard Testing Procedure (STP) and Certificates of Analysis (COA’s).
To maintain strict adherence of GLP in the analytical development laboratory.
To ensure the customer audits and regulatory inspection compliance review, pending actions monitoring and follow up compliance response.
To ensure the changes in the current regulatory guidelines and evaluation of systems for ongoing improvements. Observing and complying with company Health and Safety Policies.

Job description

Responsibility:

Review of Analytical Method Validation, Verification, Vendor Qualification, Cleaning validation and Method transfer protocols and reports.
Review of method development and routine stability analysis data.
Review of certificate of analysis and stability data sheet.
To guide team member for development of novel and cost-effective analytical methods.
To perform all type of analysis like Method validation, method verification, method transfer, stability analysis and regulatory query support related work and its documentation as and when required.
To perform and review maintenance and calibration of analytical instruments and its documentation.
To ensure that appropriate safety procedures are followed in the laboratory.
To verify the Contract Giver analytical methods and execute the project scope within the stipulated time frame.
Review of SOP, Specification, Standard test procedure and worksheets as and when required.
To provide on the job training and on advance topics as and when required.
Preparation and Review of Standard Testing Procedure (STP) and Certificates of Analysis (COA’s).
To maintain strict adherence of GLP in the analytical development laboratory.
To ensure the customer audits and regulatory inspection compliance review, pending actions monitoring and follow up compliance response.
To ensure the changes in the current regulatory guidelines and evaluation of systems for ongoing improvements. Observing and complying with company Health and Safety Policies.