QCM

· To manage, plan and direct the Quality Control and Microbiology laboratories

· To ensure the quality of product, physically, chemically and biologically.

· To ensure lab testing is providing the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations

· To control and arrange the testing of starting materials, packaging materials, intermediate, bulk, finished product and also rejected materials.

· To execute and approve all laboratory investigations

· To review and sign lab related documentation

· To review and approve protocols and reports including method validation, method transfer, process validation and stability studies

· To provide leadership, management, evaluation and training to all laboratory employees

· To evaluate the batch records (BMRs). This should be done as part of the product release process

· To reassure that products have been produced in accordance to the SOPs and meet specifications

· To approve quality control procedures, e.g. sampling and testing; specifications

· To develop all lab related instructions, policies and procedures

· All the required instructions must be pasted at proper places

· To develop standard operating procedure of instruments and their calibration

· To check and arrange the calibration of quality control equipment

· To coordinate with Plant Manager and Production department to maintain the Quality of Products

· To investigate and coordinate with Sales, Quality Assurance and Production Department in case of any customer complaint

· To coordinate with HR department and Plant Manager for annual performance appraisal of QC staff

· To approve/reject leaves of QC staff

· To check and ensure performance of endotoxin testing, fills out the log and reviews results

· To check and ensure performance of sterility testing using traditional and rapid scan methods

· To check and ensure receiving of sterility testing samples, verify source information, document it and place in the appropriate incubators

· To check and ensure performance of visual inspection the sterility samples and prepare the reports for the final review

· To check and ensure the reading of the environmental monitoring plates, analyze data and compile the reports

· To check and ensure performance of growth promotion and bio burden testing

· To check and ensure qualification of laboratories for identification analysis of microorganisms

· To check and ensure the sending of the samples out to the qualified laboratories for microbial ID

· To check and ensure preparation of quarterly testing reports

· To check and ensure preparation of monthly trend analysis & review and revise SOPs of microbiology

· To check and ensure performance of gowning qualification for cleanroom personnel

· To check and ensure performance of aseptic technique verification for new hires

· To check and ensure qualification of pharmacy tech (media fill), documentation, protocol and prepare final reports

· To check and ensure performance documentation growth promotion test

· To check and ensure maintenance of microbiology laboratory equipment

· To check and ensure training the new laboratory personnel

· To check and ensure maintenance the laboratory temperature logs including chemical and micro labs

· To check and ensure the testing of raw materials, intermediates and finished products using current pharmacopoeias, any associated ‘wet’ chemistry and instrumental techniques (HPLC, IR, UV), as appropriate.

· To check and ensure preparation 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 check and ensure creation and execution of method development and method validation test protocols for finished products and generate the appropriate analytical methods

· To check and ensure stability testing of products for new formulations and ongoing stability trials, using physical (pH, viscosity) and instrumental (HPLC, UV) techniques, as appropriate

· To check and ensure writing of analytical specifications using current pharmacopoeias and review existing analytical specifications

· To check and ensure writing/review Standard Operating Procedures (SOPs) for QC Department

· To check and ensure calibration of analytical equipment, as and when required

· To check and ensure compliance with company Standard Operating Procedures (SOPs)

· To check and ensure maintenance laboratory equipment

Job Type: Full-time

Pay: Rs130,000.00 - Rs150,000.00 per month

Work Location: In person