To prepare, review, approve and distribute the instructions for the production of intermediates and Final product according to written procedures and SOPs.
Production planning, monitoring and controlling of intermediates and final product according to written procedures and SOPs.
To review all production batch records and ensuring that these are completed and signed.
To ensure that all production deviation are reported and evaluated and all critical deviation are investigated and conclusions are recorded.
To ensure that documentation is on line and entries are made as per requirement.
To ensure that production facilities are clean and when appropriate disinfected to control Environmental and Microbial condition in clean room and other production area as per respective SOP. Also ensure that all records are maintained.
To ensure weighing and dispensing of raw material and packing material as per requirement and Ensuring timely availability of material for smooth production.
To ensure smooth material flow for timely availability material or semi finish good for next stage of process.
To ensure timely and efficient execution of production targets.
To ensure identification status of process, material, semi finish good, machines and equipment at each level.
To monitor of rejection at various stages of process and analyze it and reduce it by effective monitoring, analyzing and eliminating the root cause.
To take prompt action for any break down maintenance as well as preventive maintenance of machines and equipment.
To review and implementation of SOPs and other documents as per requirement.
To evaluate proposed changes in product, process or equipment. Also to ensure that new and when appropriate, modified facilities and equipment are qualified.
To co-ordinate with other supporting dept. like Engineering, QA, QC, stores and warehouse etc
To ensure validation and calibration status of process and equipment and measuring devices and ensure that all related protocols and reports are reviewed and approved.
To investigate market complaints and take corrective action accordingly.
To attend organization meeting for production points.
To provide trainings to subordinates.
To ensure safety and health status of personnel. To take prompt action in case of any emergency.
To work for productivity enhancement, cost saving and improvements.
Functional reporting shall be as per departmental organogram.
Any other task assigned by Reporting Manager/Seniors.
The responsibilities may be reviewed/added as per company requirements from time to time.
Required Candidate profileEducation:(UG - B.Sc - Any Specialization) OR (PG- MS/M.Sc(Science) - Bio-Chemistry, Microbiology) AND (Doctorate- Any Doctorate - Any Specialization, Doctorate Not Required)
Educational Qualification Required:
Min : B.Sc.
Desirable : M. Sc.(Biotech/Microbiology)
Special Skills: Work experience of Medical Device or Pharma Industry
Problem Solving skills, Communication skills, Team handling skills, GMP, Drug Guidelines
Experience 15-20 years
Salary: Not Disclosed by Recruiter
Desired Candidate Profile
UG:Other Graduate, B.Sc - Any Specialization
PG:Other, MS/M.Sc(Science) - Any Specialization
Doctorate:Doctorate Not Required
J.Mitra and Co. Pvt. Ltd
Contact Company:J.Mitra and Co. Pvt. Ltd