Deputy Quality Control
17 hours ago
· Sufficient samples of starting materials and products are retained to permit future examination of the product.
· Complaints related to the quality of the product are investigated.
· All tests and analysis conducted shall be in accordance with the instructions given in the relevant written test procedures. The result shall be checked by the supervisor before the material or product is released or rejected.
· Identity from each container.-- An identity test shall be conducted on a sample from each container of starting material.
Records of testing.- In process control records shall be maintained and form a part of the batch records.To support QCM in all QC activities
To test raw materials, intermediates and finished products using current pharmacopoeias, any associated 'wet' chemistry and instrumental techniques (HPLC, IR, UV), as appropriate.
To prepare Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports and get them signed from QCM
To create and execute method development and method validation test protocols for finished products and generate the appropriate analytical methods
To conduct stability testing of products for new formulations and ongoing stability trials, using physical (pH, viscosity) and instrumental (HPLC, UV) techniques, as appropriate
To write analytical specifications using current pharmacopoeias and review existing analytical specifications
To write/review Standard Operating Procedures (SOPs) for QC Department
To calibrate analytical equipment, as and when required
To comply with company Standard Operating Procedures (SOPs)
To maintain laboratory equipment
To train the new laboratory personnel
To perform any other duty assigned by the line manager
To check and ensure the performance of gowning qualification for cleanroom personnel
To check and ensure the performance aseptic technique verification for new hires
To check and ensure the qualification of pharmacy tech (media fill), documentation, protocol and preparation of final reports
To check and ensure the performance and document growth promotion test
To check and ensure the maintenance microbiology laboratory equipment
To check and ensure the training of the new laboratory personnel
To check and ensure the maintenance the laboratory temperature logs including chemical and micro labs
To perform the following tasks as per the schedule BII checklist and have the data ready for presentation for the audit at all times
· All necessary controls on starting materials, intermediate products, and bulk products and other in process controls calibrations are carried out;
· Records are made that all the required inspecting and testing procedures have actually been carried out and that any deviation has been fully recorded and investigated;
Records are made of the results of inspecting and testing materials and intermediate, bulk against specifications and product assessment
Job Type: Full-time
Pay: Rs70, Rs100,000.00 per month
Work Location: In person
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