Manager - Manufacturing - Pharmaceutical Industry (10-14 yrs)
Job Description :
We are currently hiring for Manufacturing (Production) professionals who are expertise in Upstream & Downstream Process ( Mammalian Cell culture) for our leading pharmaceutical Client.
Designation : Manager
Department : Manufacturing
Experience : 10 + Years
Education : B.Tech ( Biotech/ Bioprocess Engg/ Chemical/ Industrial Biotech)
Division : Biologics
Mandatory Skills : Must have hands on experience in Bioreactors/ Fermentors/ Mammalian Cell culture / TFF/ Classification System / UFDF/ "MAPS"/ Autoclave.
Manufacturing (Downstream Process) :
1. Responsible for technical evaluation, finalization and ordering of process equipment.
2. Oversee and assist in commissioning and qualification of equipment in downstream process and ancillary area.
3. Assist in technology transfer from Process Development and scale-up as per the requirement.
4. Responsible for all downstream process activities of clinical & commercial manufacturing as per cGMP guidelines in order to obtain the required quality of product.
5. Responsible for Process Validation in support of regulatory filing.
6. Preparation and monitoring of production planning and inventory control.
7. To comply with national and international quality and regulatory standards and always be ready for all kinds of internal and external audits.
8. Reviewing process scale-up protocols, developmental/technical reports, SOPs, cleaning validation protocols, Batch Manufacturing Records etc. and to ensure their strict implementation.
9. To give required initial and continuing training to subordinates as per their training needs.
10. Co-ordinate with QC, QA & Engineering for analysis, GMP compliance and smooth running of the day to day activities in manufacturing facility.
11. To ensure the work place safety, health of all the personnel involved in downstream process.
12. Responsible for handling deviations, change controls and carrying our investigations
Interested kindly drop your profile
Sivaperuman.D.S
Associate - Pharma Intellect Acquisition
Desired Candidate Profile :
Education :
- B.Pharma - Pharmacy, B.Sc - Any Specialization, B.Tech/B.E.
- MS/M.Sc(Science) - Any Specialization, M.Tech
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