M.SC OR PH.D. IN ORGANIC CHEMISTRY
Experience: 3-12 years
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
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.
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.
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
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.
Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We offer solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe.
We are a team of more than 5,000 unique talents bonded together by our purpose to provide health and wellbeing for all generations. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated and can be their true selves contributing to the best of their ability.
Data protection: It’s not just a checkbox – it’s our commitment! Please visit our Privacy Notice https://www.zentiva.com/gdpr/privacy-notice
