General Manager Quality Assurance at Galpha Laboratories Limited

•To ensure CGMP/GLP, GXP Compliances and ensure that all QMS documents like change control, deviation, CAPA, market complaints, incidents, OOS, OOT, OOC and LEIR etc. are reviewed and approved as per procedure

•To approve artwork of new products/ modified products, validation protocol and report, qualification protocol and report, stability protocol and report.

•To ensure timely completion of all validation and qualification activities as per defined schedule.

•To ensure the equipment and utilities requalification as per defined schedule and to approve and monitor the contract services providers including technical agreements

•To ensure the stability studies are conducted for all products as per requirement and batches manufacturing as per cGMP requirement and to ensure the control sample management.

•Review and decision making authorization on disposition of batches of products in the case of non- compliances or non-defective material to decide on its rejection or repacking.

•Periodic review of documents, analytical data as and when required and to ensure investigation of all market complaints are done in timely manner and to ensure that required CAPA s are implemented to avoid reoccurrences.

•To ensure principles and application of risk management. Overview of the breakdown, planned preventive maintenance and calibration schedule.