Executive

Role & responsibilities Preparation and review of Validation master plan Handling of qualification and Validation related activities. Qualification of new equipments at site and preparation of DQ, IQ, OQ and PQ. Responsible for communicating with approved outside laboratories to perform all validations as per validation master plan. Responsible for review of outside laboratories reports. Responsible for review routine validation of all validations like HVAC Validation, cartridge filter validation, CIP/ SIP validation, autoclave validation etc. Preferred candidate profile Handling of final release of batch of finished product through ERP. Implementation of Good documentation Practices Preparation and Compilation of Protocol and Report. Active participation in Internal Audits and Vendor Audit. Preparation and Review of Sops. Of concerned Department. Review of environmental monitoring records of all areas. Handling of QMS activities. Handling of artwork. Preparation of new BOM in ERP. Issuance of monthly formats and log books. Retrieval of final batch records from production department. Maintaining the control sample records. To check the environmental condition of respective area and fill the formats Updation of MRP list. Review of Finished COA Final batch record and COA data entry in to APQR. Preparation of Water trend of each stage. Issuance of BMR and BPR. Involve in all IPQA activities. Review of batch records and finally check the reconciliation of yield of batch. Temperature, RH, and Differential pressure monitoring in control area. Updation of related log book and formats of related area.