Responsible for ensuring that the appropriate Analytical method validation/Analytical method verification/Analytical method transfer including those of analytical procedures and calibration of equipment are done.
Responsible for overall functioning of the quality control department.
Responsible for review and updating of specifications for raw material packaging material, finished product and test method to ensure compliance with statutory and company standards.
Responsible for monitoring of the manufacturing environment in association with production as a part of quality assurance.
Responsible for formal investigation of out of specification laboratory results and documentation of such investigation including action taken.
Responsible for investigation of product complaints and reporting of results of such investigation.
Responsible for compliance with all statutory requirements including those concerning the labelling of products.
Responsible for equipment of the laboratories with adequate glassware, chemical, instruments and personnel to discharge the functions of quality control.
Responsible for training of staff in laboratory techniques, general analytical methods quality control procedures and principles of currents good manufacturing practices / General laboratory practices.
Responsible for ensuring that all necessary testing is carried out as well as stability studies and quality review.
Responsible for approving and monitoring analysis carried out under contract.
Responsible for checking the maintenance of the department, premises and equipment.
Responsible for ensuring that the required initial and continuing training of quality control personnel is carried out and adapted according to need.
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 procedure were actually carried out. Any deviation is 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 sufficient reference samples of starting materials and finished products are retained to permit future examination of the product if necessary and the product is retained in its final pack unless exceptionally large packs are produced.
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 specification before release for further manufacture or sale. It includes online quality control, intermediate and in process controls using production staff while quality control provides technical support and audit.
Responsible for inspection, investigation and taking of samples, in order to monitor factors which may affect product quality.
Responsible for review of standard operating procedures, instrument operating procedure and equipment operating procedure.
Responsible for establishing or approving adequately detailed instructions for carrying out all tests required in connection with the quality control of materials and products.
Responsible for establishing procedures for the microbiological testing and microbiological monitoring of materials, products and environment including process water.
Responsible for revising the revision of the established quality control specifications and sampling and testing instruction as necessary, replacing superseded versions and maintaining a complete written collection of the current version and an historical record of amendments.
The quality control department head/ designee also has responsibilities in the following areas;
Validation of critical equipment and procedures.

More Jobs at Zenzi Pharmaceutical Industries

Assistant Manager-Quality Control

murbad

12.0 - 15.0 yrs

INR 8 - 10 Lacs

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