ASSISTANT MANAGER

Department Details

Role Summary

Role 1 - Job Description 1) Overall responsible as part of QA professionals for Engineering and QA team for activities like facility, equipment, computer and automated systems during Qualifications, Validations, Calibrations and Role & Responsibilities. 2) Responsible for preparation FVMP, CSVMP and ensuring all validations are conducted as per schedules and procedures 3) Responsible for review, issuance, training, control, reconciliation, retrieval and approval of GMP documents like validation protocols, reports, plan, formats, records, logbook etc. 4) Responsible for ensuring all qualification at site facilities, equipment, utilities, computer systems qualifications, validations, calibrations, maintenance, risk assessments are executed as per defined schedules and procedures in accordance with cGMP and GAMP standards 5) Responsible for ensuring Risk Assessment is performed for all equipment, facilities, computer systems, utilities as applicable are executed and defined controls of GAMP requirements. 6) Responsible for prepare, review and approval QMS documents like other department SOP's, change controls, deviation, CAPA, QA SOPs, pertaining to Engineering & QA 7) Responsible for part of investigations team and review of investigation reports, identifying CAPA and effective monitoring for implementation, pertaining to Engineering & QA 8) Participate in internal and external audits, provide and implement appropriate technical responses and action plan during the audit. Identifying, monitoring compliance to CAPA identified as an outcome of audit observations 9) Responsible for ensuring elements of Quality Management Systems are assessed and completed as per set timelines. Perform risk assessments as applicable 10) Involve in improvement plans by effective quality gap analysis programs, from the learnings obtained as part of site audits as well as with changes in the regulatory expectations 11) Participate in GMP rounds and reporting observations as per procedure 12) To actively participate QMS meetings with peers and superiors. Update and discuss issues, if any with the senior management in order to find an effective solution keeping product quality, safety and efficacy as the top priority 13) Responsible for supporting quality review meeting as per procedure 14) To prepare and review the documents and records for the applicable section as and when required 15) Member of Change Management, Deviation Management and CAPA review panel which involves assessing the changes, deviations and CAPA, the impact of the change and deviation 16) To support customer focus/client/partner relationship 17) Coordinate with Biocon India, Bangalore for harmonized QA procedures at Biocon Sdn. Bhd. 18) Ensure that engineering operations, qualifications, validations are executed using approved materials and procedures, trained / qualified / certified people, validated processes, calibrated s 19) Participate in Internal & external training and audits within qualification and validation scope in building better understanding, identifying gaps and be in current with validation and quality approach 20) Responsible for review of cleaning validation, contamination control assessments, risk assessments of site in view of engineering controls 21) Qualification of Black Utility, Cleanroom HVAC and LAF/ RABS Equipment and Weighing Balance in DS and DP Building 22) Familiarization of function and activities for QC, Production, Warehouse and Environment, Health & Safety

Key Responsibilities

Role 1 - Job Description 1) Overall responsible as part of QA professionals for Engineering and QA team for activities like facility, equipment, computer and automated systems during Qualifications, Validations, Calibrations and Role & Responsibilities. 2) Responsible for preparation FVMP, CSVMP and ensuring all validations are conducted as per schedules and procedures 3) Responsible for review, issuance, training, control, reconciliation, retrieval and approval of GMP documents like validation protocols, reports, plan, formats, records, logbook etc. 4) Responsible for ensuring all qualification at site facilities, equipment, utilities, computer systems qualifications, validations, calibrations, maintenance, risk assessments are executed as per defined schedules and procedures in accordance with cGMP and GAMP standards 5) Responsible for ensuring Risk Assessment is performed for all equipment, facilities, computer systems, utilities as applicable are executed and defined controls of GAMP requirements. 6) Responsible for prepare, review and approval QMS documents like other department SOP's, change controls, deviation, CAPA, QA SOPs, pertaining to Engineering & QA 7) Responsible for part of investigations team and review of investigation reports, identifying CAPA and effective monitoring for implementation, pertaining to Engineering & QA 8) Participate in internal and external audits, provide and implement appropriate technical responses and action plan during the audit. Identifying, monitoring compliance to CAPA identified as an outcome of audit observations 9) Responsible for ensuring elements of Quality Management Systems are assessed and completed as per set timelines. Perform risk assessments as applicable 10) Involve in improvement plans by effective quality gap analysis programs, from the learnings obtained as part of site audits as well as with changes in the regulatory expectations 11) Participate in GMP rounds and reporting observations as per procedure 12) To actively participate QMS meetings with peers and superiors. Update and discuss issues, if any with the senior management in order to find an effective solution keeping product quality, safety and efficacy as the top priority 13) Responsible for supporting quality review meeting as per procedure 14) To prepare and review the documents and records for the applicable section as and when required 15) Member of Change Management, Deviation Management and CAPA review panel which involves assessing the changes, deviations and CAPA, the impact of the change and deviation 16) To support customer focus/client/partner relationship 17) Coordinate with Biocon India, Bangalore for harmonized QA procedures at Biocon Sdn. Bhd. 18) Ensure that engineering operations, qualifications, validations are executed using approved materials and procedures, trained / qualified / certified people, validated processes, calibrated s 19) Participate in Internal & external training and audits within qualification and validation scope in building better understanding, identifying gaps and be in current with validation and quality approach 20) Responsible for review of cleaning validation, contamination control assessments, risk assessments of site in view of engineering controls 21) Qualification of Black Utility, Cleanroom HVAC and LAF/ RABS Equipment and Weighing Balance in DS and DP Building 22) Familiarization of function and activities for QC, Production, Warehouse and Environment, Health & Safety

Educational Qualifications

Required Education Qualification: B.Pharma
Required Experience: 1 - 10 years