Senior Laboratory Compliance Officer

3 days ago


Ankleshwar, Gujarat, India beBeeQualityAssurance Full time ₹ 8,00,000 - ₹ 12,00,000

Job Title: Quality Assurance Specialist

This role is a crucial part of ensuring the quality and safety of products. As a Quality Assurance Specialist, you will be responsible for maintaining adherence to Good Laboratory Practices (GLP) and ensuring compliance with regulatory requirements.


Responsibilities:
  1. Maintain strict adherence to GLP principles in laboratory operations.
  2. Issue work data sheets/protocols from the Quality Assurance Department.
  3. Work as an Analyst and ensure compliance with current Good Manufacturing Practices (cGMP) and 21 CFR Part 11 regulations.
  4. Perform wet analysis of finished products, returned goods, raw materials, hold time, stability study, and working standard analysis.
  5. Record results in work sheets (Protocols) as per current specifications and methods of analysis.
  6. Perform sampling of intermediates, returned goods, hold time of intermediate samples, stability study, and working standard samples and finished products.
  7. Report analysis data in Laboratory Information Management System (LIMS) modules and report to Section Head if required.
  8. Ensure that every specification and method of analysis used is for the right product/material code.
  9. Follow instructions of Shift/Section In charge for analysis/planning.
  10. Maintain instrument history records.
  11. Report and raise any Quality Issues (QI), Non-Conformity (NQI), Out-of-Specification (OOS), Out-of-Trend (OOT), deviation or discrepancy in laboratory analysis to QC-In charge.


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