To coordinate for the commissioning of all the equipment’s at different area of production and completion of all documents such as DQ /IQ/OQ/PQ before the commencement of the regular production.
To ensure that the total shift operation in Production Department starting from Dispensing to Packing is done with adherence to cGMP.
To coordinate and follow up with other departments to ensure the timely generation / availability / release / dispensing /dispatch / processing / analysis of required Process Order / material / BMRs / documents etc.
To ensure the optimum utilization of equipment and material as required qualitative and quantitative outputs and also improve product quality at every stage of the Production.
Preparation, review and implementation of the SOPs / BMRs / BPRs/ Annual product review, process validation protocol/ report, hold time study protocol/ report, equipment / facility qualification protocol/ report and provides hands-on job training to operators.
To find out and intimate the requirements for change part, accessories, spares and consumable to the department head.
To participate in manufacturing investigations against OOT/OOS, Deviation, Root cause analysis of manufacturing failure, implementation of CAPA, prepare and review the manufacturing investigation
Preparation and review of the qualification and validation documents across the department.
Having good communication skill and good hand in MS excel, office and SAP.
Work Experience08 to 12 years of experience of good reputed companies of pharma sector
Education GraduationMasters in Pharmacy or Pharmaceutical TechnologyCompetencies Result OrientationCollaborationStakeholder ManagementProcess ExcellenceInnovation & CreativityDeveloping TalentStrategic AgilityCustomer Centricity