Skills:
§ Coordinating with Quality Assurance, Quality Control, and Technical Services in preparation of necessary document like User Requirement and process related document like BMR, SOP, Change control, Investigation report, APQR.
§ Involved in review and preparation of validation protocol and handling of deviation and change controls.
§ Update the production process and implement the operations in a new version of batch process.
§ To give pre-intimation to QC department for Analysis requirement of System
§ To co-ordinate with quality control for manufacturing investigation of OOS/OOT report.
§ Execution of commercial and validation batches for regulatory audit submission.
§ Ensure online data entry in the production document during process with technical supportive documents.
§ To review all production batch records and to ensure that these are compliance.
§ Preparing OQ and PQ documents and ensuring timely completion of Qualification activities
Additionally:
§ Competent Chemical Engineering Professional offering extensive experience of 18+ years, with in depth knowledge and functional experience in supporting for all functional modules in Production, Quality Assurance & Quality Control.
§ Superlative leadership qualities with excellent analytical skills with demonstrated capability to effectively use manpower and motivate professionals to maximize levels of productivity
§ Understanding of all aspects governing operational and production activities and up to date knowledge of latest technological advancements, regulations/ guidelines and statutory compliances in the industry.
