QC Manager

Contenido de trabajo

Exp: 10-15 years; Responsibilities Responsible for Overall management of Quality Control Laboratory and compliance to applicable standards. To approve or reject, as he sees fit, raw materials, packing materials, semi finished product and finished products as per agreed/approved Specification. To review and approve analytical reports, validation protocols, calibration reports, environmental monitoring planner and other documents of microbiology laboratory. Preparation and review of department SOP;s related to Quality control and microbiology laboratories. To ensure instruments are calibrated timely and review of their records. To ensure analyst are validated for required testing. laboratory instruments and procedure as per 21CER part 210,211,EU GMP and other applicable GLP regulations. To participate in the Investigation of complaints related to Quality of product. To ensure timely and effective communication with the management to raise Quality issue. Review of analytical data. To carry out investigation in case of any OOs, incidence, deviation. To involve and to participate in "Internal audit" Activities To involve and to participate in cleaning validation, method validation and process validation activities To monitor & approve water analysis trend charts. To Manage Team of 10-12 person Required Skills Good Communication Skills Basic Computer Knowledge Basic English Knowledge Required Qualification - B.Sc/M.Sc/B.Pharm/M.Pharm