Job Description

Role & responsibilities Responsible for overall operation and its compliance of Quality Control laboratory. Ensure timely testing of Water Samples, Raw/Packaging Materials, Consumable materials, In-process samples. To plan the day to day activities and follow up to be taken from supervisors for timely completion of activities Ensure the completion of Analytical Method Validations/ Verification /Transfer of testing methods (as applicable) used in the laboratory. Ensure availability of logistics (Standards, reagents/chemicals /solvents/columns/any other consumables) and ensure procurement of the same on time. To ensure timely completion of Analyst Qualifications for New Analysts (Either Fresher or Experienced) in the laboratory. Responsible to handle the trouble shooting of HPLC, IR, UV, Dissolution and GC instruments during the course of analysis. Initiating and implementing the GLP and cGMP activities in the departments. Handling and review of Incidents/Deviations, Out of Specifications, Out of Trends, Change Controls and CAPA as applicable. Review of trends and summary reports. To ensure that the required initial and continuing training of department personnel is carried out and adapted according to need. To ensure the calibration of instrument/equipment performed timely. To ensure and establish, validate and implement all quality control procedures. To participate in the investigation of complaints related to the quality of the product, etc. Responsible for CMC (Chemistry manufacturing and control) queries/ IR related to compliance. Handling of LIMS, DCS, Documentum, LMS & SAP software as per relevant procedures. Laboratory facility monitoring, up-gradation and to ensure up-keeping. Deliver all regulatory commitments on time Proactively identifying the issues impacting lab compliance, developing a plan and its implementation. Facing external audits Gap Analysis review and initiate the gap analysis closure by updating system SOPs/Practices and effective continuous monitoring. Participate in the Internal Audits/Self Inspection activity at site. To ensure retention and maintenance of analytical documents. To ensure timely submission of regulatory documents to respective regulatory agencies by coordination with QA and RA. Filling up all key positions and replacement of Manpower on time. Auditing of contract testing laboratories and API/Excipient vendors w.r.t. cGMP compliance. To maintain and ensure cleanliness of Quality Control laboratory and equipment’s. To impart SOP/IOCP trainings to new joinee and existing personal.