.
To ensure manufacturing as per SOP and timely completion of projects.
1)Plan & Execution of product manufacturing :
To facilitate Operation & changeover of process systems, debottlenecking of process hurdles
Regular interaction with Operation team, QAD and supporting functions to achieve the desired targets
Focus on plant goals in order to attain expected products over all batch yield
Coordinate and monitor the manufacturing schedule to ensure proper utilization of process units, utilities etc.
Hands on experience with bioreactors ,chromatography, TFF,CIP systems
Exposure on DCS control system would be preferable
Scale up, scale down processing of both upstream and downstream process
Upstream processing operations seed bioreactors ,production bioreactors operations ,media and buffer preparation activities
Downstream processing operations Centrifugation, Microfiltration and Ultrafiltration skid systems.
2) Review & monitoring :
To ensure the preparation of the cleaning / disinfectant solution and cleaning/fumigation of area/equipment as per the schedule and respective SOPs.
To ensure entire manufacturing activities to be performed as per respective SOP's /guidelines
To ensure that on- line entries in GMP documents like BMRs, BPRs, log-books etc. are performed as per Good Documentation Practice.
To ensure that all documents are updated/revised periodically to meet cGMP standards and as per QAD requirement
Ability to mainly evaluate schedule in accordance to manufacturing processes, and determine the most efficient method of accomplishing goals in order to meet the targets.
Supervise, coach and train new and current employees (i.e. job, safety, etc.) to meet performance expectations by providing strong leadership skill set.
3) GMP compliance, Validation and audit readiness
To co-ordinate and support for timely completion of calibration, preventive maintenance, qualification/ validation revalidation of process units as per schedule.
Ensure that safety, Good Manufacturing Practices (GMPs) and sanitation policies and procedures are met.
Process systems and manufacturing area readiness for GMP.FDA,WHO and international audits
Preparation of BMR and BPR
Validation protocols preparation and its execution
To ensure manufacturing as per SOP and timely completion of projects.
1)Plan & Execution of product manufacturing :
To facilitate Operation & changeover of process systems, debottlenecking of process hurdles
Regular interaction with Operation team, QAD and supporting functions to achieve the desired targets
Focus on plant goals in order to attain expected products over all batch yield
Coordinate and monitor the manufacturing schedule to ensure proper utilisation of process units, utilities etc.
Hands on experience with bioreactors ,chromatography,TFF,CIP systems
Exposure on DCS control system would be preferable
Scale up, scale down processing of both upstream and downstream process
Upstream processing operations # seed bioreactors ,production bioreactors operations ,media and buffer preparation activities
Downstream processing operations # Centrifugation, Microfiltration and Ultrafiltration skid systems.
2) Review & monitoring :
To ensure the preparation of the cleaning / disinfectant solution and cleaning/fumigation of area/equipment as per the schedule and respective SOPs.
To ensure entire manufacturing activities to be performed as per respective SOP's /guidelines
To ensure that on- line entries in GMP documents like BMRs, BPRs, log-books etc. are performed as per Good Documentation Practice.
To ensure that all documents are updated/revised periodically to meet cGMP standards and as per QAD requirement
Ability to mainly evaluate schedule in accordance to manufacturing processes, and determine the most efficient method of accomplishing goals in order to meet the targets.
Supervise, coach and train new and current employees (i.e. job, safety, etc.) to meet performance expectations by providing strong leadership skill set.
3) GMP compliance, Validation and audit readiness
To co-ordinate and support for timely completion of calibration, preventive maintenance, qualification/ validation revalidation of process units as per schedule.
Ensure that safety, Good Manufacturing Practices (GMPs) and sanitation policies and procedures are met.
Process systems and manufacturing area readiness for GMP.FDA,WHO and international audits
Preparation of BMR#s and BPR#s
Validation protocols preparation and its execution
