Develop and promote a culture of quality awareness of the sense of quality all over the plant i.e. relating to all inputs in the form of raw materials, supporting chemicals & solvents. To ensure compliance with all quality checks by all concerned at each point of operations as per already approved protocols and SOPs. To ensure that the first target of all personnel in every department should be to ensure that they have acquired the highest sense of quality consciousness. Review batch manufacturing and testing records, before giving product release. Ensure compliance of national and international regulatory WHO & cGMP requirements. Review and authorize validation master plan, and protocols and provide support for validations. Approved and verify implementation of defined protocols and SOPs standards and procedures.
Ensure that the approved procedures and specifications, for reference, are duly in place. Ensure compliance with change management procedures. Ensure induction and training of employees as per induction and training policy. Ensure compliance with WHO-cGMP and related procedures of Drugs (Registering, Licensing & Advertising) Rules, 1976. Carry out process controls, including in-process checks/ inspections. Inspection of all shippers packed before release and related dispatches. Investigate complaints, deviations, quality incidents, and non-conformances. Coordination of regulatory inspections at the site. Take action on product recalls and investigate the reasons. Ensure availability of latest quality standards i.e. B.P & U.S.P.
Periodically review of batch manufacturing records during manufacturing & at the time of product release. Ensure WHO-GMP training for the staff. Annual product quality review. Vendor evaluation activity of approved & new vendors. Support validation activities. Internal audit. To review and approval of master validation program, including equipment, processes, HVAC, water system, cleaning validation, etc. To investigate out-of-specification results related to testing or manufacturing etc. To review and upgrade the quality systems as per the latest regulatory requirements on a periodical basis. To review SOPs related to quality assurance and manufacturing activities. To ensure sampling of raw materials as per defined procedures.