Senior Executive

Department Details Role Summary Primary Responsibilities 1 Responsible for all qualification and validation activities of facility equipment and at site 2 Drug substance facilities includes B1 B3 B4 B5 QC-Q8 QC-Q17 QC-Q19 QC-Q19B W20 and W21 2 Review and approval of documents related to Commissioning and Qualification URS to PQ RQ SOPs for equipment utility operation and Engineering SOP s as applicable 3 Preparation and review of Standard Operating Procedures relevant to qualification validations and to impart training Including General Training relevant to the team 4 Monitoring of commissioning and qualifications FAT SAT IQ OQ IOQ PQ RQ of equipment facility and utilities at site 2 Drug substance facilities 5 Review and approval of periodic re-qualification planner and regular follow-ups for performing the qualifications within the due date 6 Review and approval of Calibration Preventive Maintenance planner and ensuring the calibration and preventive maintenance activities done as per planner 7 Review of QMS documents like Change Controls Deviations and Risk Assessment related to Equipment Utility and facility as applicable 8 Support during investigations and to suggest review CAPA related to facility utility and equipment as applicable 9 Review and approval of facility utility and equipment layouts 10 Preparation Review and approval of FRP 11 Shopfloor inspection QA on shopfloor to check compliance engineering relevant aspects to cGMP cGEP at regular intervals 12 Support relevant to engineering and maintenance aspects during regulatory and customer audits 13 Issuance and control of qualification related protocols and documents as applicable 14 Support all the activities that are taken to enhance the facility and systems as per regulatory requirements 15 Educate training to cross functional teams on quality requirements operating procedures relevant to Engineering QA aspects 16 Ensure safe work practices are followed at workplace 17 Follow GDP while preparation review and approval of documents 18 Adhere to the Data Integrity Policy of Biocon 19 Timely completion of assigned trainings in LMS as per revision and annual refresher training planner 20 Ensuring cGMP requirements while performing and reviewing of qualifications validations Secondary Responsibilities 1 Support continuous improvement initiatives identified within Engineering QA functions 2 Technical support for site engineering and maintenance teams as required 3 Contribute for harmonization of SOPs across multiple Biocon sites 4 Provide a backup support for routine activities in case of emergency 5 Any other responsibility assigned by Head QA Designee Key Responsibilities Primary Responsibilities 1 Responsible for all qualification and validation activities of facility equipment and at site 2 Drug substance facilities includes B1 B3 B4 B5 QC-Q8 QC-Q17 QC-Q19 QC-Q19B W20 and W21 2 Review and approval of documents related to Commissioning and Qualification URS to PQ RQ SOPs for equipment utility operation and Engineering SOP s as applicable 3 Preparation and review of Standard Operating Procedures relevant to qualification validations and to impart training Including General Training relevant to the team 4 Monitoring of commissioning and qualifications FAT SAT IQ OQ IOQ PQ RQ of equipment facility and utilities at site 2 Drug substance facilities 5 Review and approval of periodic re-qualification planner and regular follow-ups for performing the qualifications within the due date 6 Review and approval of Calibration Preventive Maintenance planner and ensuring the calibration and preventive maintenance activities done as per planner 7 Review of QMS documents like Change Controls Deviations and Risk Assessment related to Equipment Utility and facility as applicable 8 Support during investigations and to suggest review CAPA related to facility utility and equipment as applicable 9 Review and approval of facility utility and equipment layouts 10 Preparation Review and approval of FRP 11 Shopfloor inspection QA on shopfloor to check compliance engineering relevant aspects to cGMP cGEP at regular intervals 12 Support relevant to engineering and maintenance aspects during regulatory and customer audits 13 Issuance and control of qualification related protocols and documents as applicable 14 Support all the activities that are taken to enhance the facility and systems as per regulatory requirements 15 Educate training to cross functional teams on quality requirements operating procedures relevant to Engineering QA aspects 16 Ensure safe work practices are followed at workplace 17 Follow GDP while preparation review and approval of documents 18 Adhere to the Data Integrity Policy of Biocon 19 Timely completion of assigned trainings in LMS as per revision and annual refresher training planner 20 Ensuring cGMP requirements while performing and reviewing of qualifications validations Secondary Responsibilities 1 Support continuous improvement initiatives identified within Engineering QA functions 2 Technical support for site engineering and maintenance teams as required 3 Contribute for harmonization of SOPs across multiple Biocon sites 4 Provide a backup support for routine activities in case of emergency 5 Any other responsibility assigned by Head QA Designee Educational Qualifications Required Education Qualification Msc Required Experience 3 - 5 years