Executive-Quality Control

Zenzi Pharmaceutical Industries; Murbad; On-site; INR 600,000 - 900,000; Full time

Job summary

Zenzi Pharmaceutical Industries Pvt. Ltd. is seeking a Quality Control professional to Review analytical data, validate methods, transfer methods, and oversee in-process, raw material, and finished product testing to ensure regulatory and company standards are met.

The role includes updating specifications, performing stability and photostability studies, ensuring proper labelling, and maintaining laboratory equipment and records in line with Good Laboratory Practices.

Responsibilities

• Review analytical data and analysis of analytical method validation and method transfer.
• Review and update specifications for raw materials, packaging materials, finished products and test methods to ensure compliance with statutory and company standards.
• Perform and review stability, photostability studies and associated documentation.
• Ensure compliance with statutory requirements including product labelling.
• Ensure laboratory equipment is adequate and properly maintained to discharge Quality Control functions.
• Follow Good Laboratory Practices and ensure all testing is performed including stability studies and quality reviews.
• Calibrate instruments and check maintenance of department, premises and equipment.
• Oversee validations of analytical procedures and calibrations, and ensure adequate standards and reagents are maintained.
• Record sampling, inspection and testing procedures and investigate deviations.
• Prepare and standardize working standards and maintain reference standards.
• Assist the Head Quality Control/Supervisor with other assignments.

Job description

• Responsible for Review of Analytical data, analysis of Analytical method validation, Method transfer, inprocess, Raw material and finished dosages.
• Responsible for preparation and review of analytical method validation, Method transfer protocols and reports.
• Responsible for Review and updating of specifications for raw material, packaging material, finished products and test methods to ensure compliance with statutory and company standards.
• Responsible for analysis stability study & photostability study and review of this documents.
• Responsible for compliance with all statutory requirements including those concerning the labelling of products.
• Responsible for equipment of the laboratories with adequate glassware, chemicals, instruments and personnel to discharge the functions of Quality Control.
• Responsible for follow good laboratory Practices.
• Responsible for ensuring that all necessary testing is carried out as well as stability studies and quality review.
• Responsible for calibration of instruments.

Responsible for checking the maintenance of the department, premises and equipment.

• Responsible for ensuring that the appropriate validations, including those of analytical procedures and calibrations of equipment are done.
• Responsible for ensuring that the adequate standards and reagents are maintained.
• Responsible for ensuring that the records are made manually and/or by recording instruments to demonstrate that all the required sampling, inspection and testing procedures were actually carried out. Any deviations are fully recorded and investigated.
• Responsible for ensuring that the finished product complies with all legal requirements and is enclosed within its specified container and correctly labelled.
• Responsible for ensuring that the records which are made of the results of inspection and testing of materials, intermediates, bulk and finished products are formally assessed against specification.
• Responsible for actual sampling and testing procedures and the actual sampling and testing of starting materials, intermediate products and finished products to verify that they meet the specifications before release for further manufacture.
• Responsible for review of standard operating procedures, instrument operating procedure and equipment operating procedure.
• Responsible for preparation and standardization of working standards and up keeping of Reference standards.

Any other assignment allocated by the Head Quality Control/Supervisor.