Job Description

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Posted Date :
05 Apr 2023
Function/Business Area :
Life Sciences
Location :
Nashik
Job Responsibilities : . 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

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 executio Education Requirement :

• Graduate or Post graduate in Science, B.E in biotech engineering

Experience Requirement :

• Having minimum 0-1 years# experience.
• Demonstrated ability to effectively supervise, lead and build relationships at all levels within the company.

Skills & Competencies : Safety Requirements: Carrying out activities related to Occupational Health, Safety and Environment Management as per SOP Awareness/Knowledge on the consequences of not following Standard Operating Procedures related to Occupational Health, Safety and Environment Management
.