zentiva
Website:
zentiva.com
Job details:
JOB TITLE
Assistant Manager : Manufacturing Science and Technology (MST)
Requirements
Education / Experience
M.SC OR PH.D. IN ORGANIC CHEMISTRY
Experience: 3-12 years
Technical Skills &
Competencies / Language
- Knowledge of modern organic Chemistry
- Knowledge of performing synthetic experiments.
- Application of varied analytical methods.
- Troubleshooting
- Knowledge of design of experiments (DOEs).
- Knowledge of Quality by Design (QbD).
Zentiva values
- Accountability, Authenticity, Collaboration, Courage and Trust
Job Purpose
Generic
Providing synthetic organic chemistry expertize for the development of processes for APIs/intermediates and DMF compilation support to the customer
, ensuring compliance to regulatory, group directives, quality requirements, safety standards and effective utilization of resources, transversal cooperation with cross functional teams to fulfill the organization’s objective, living Group’s Values and Code of Ethics
Key Accountabilities
Process development:
Execute experiments with analysis on own in laboratories for developing cost-effective processes of APIs/intermediates
Isolation, Purification and characterisation of APIs/intermediates/impurities
Facilitate Technology transfers/ shift in charge in case of Pilot plant technology transfer/production
Support the production team for investigation of deviations. Identify the root cause, perform the experiments and provide a concise report to QA.
Providing required data for the DMF compilation.
New ideas generation for new APIs/Intermediates/COGs estimation
Timely closure of experiments and data compilation in report format.
CGMP
Compliance to current GMP/Regulatory guidelines.
Compliance to local and global norms of Quality/Regulatory and HSE.
Regulatory compliance (Global/Local)
Regular Pharmacopoeia and regulatory requirement review
Training of self and subordinates on quality and HSE systems.
Instrumentation
Effective use of Electronic Lab Notebook (ELN) for recording lab experiments making sure each experiment is signed and closed electronically within stipulated time.
Knowledge of NMR, Mass, HPLC, GC, UV, FITR, DSC, etc for interpretation of results
Must follow the data integrity principles
Other
Complying to HSE Requirements
Identifying and correcting unsafe conditions or behaviours and promptly reporting others potentially hazardous situations.
Lab maintenance and asset preventative maintenance activities.
Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
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