Sr. Executive II - Pilot Plant, Chemistry
Date de publication :
20 septembre 2024Taux d'activité :
100%- Lieu de travail :Ankleshwar
Education / Experience
- Diploma / Degree in Chemical Engineering OR Graduate in Chemical Engineering (B.TECH) OR Graduate / Post Graduate in Organic Chemistry
- Experience: 6-8 years
Technical skills & Competencies / Language
- Knowledge of basic automation systems in manufacturing
- Awareness of data integrity
- Knowledge of GMP documentation related to Pilot plant .
- Calculating the utility requirements.
- Calculating the Mass and energy balances for the process.
- Understanding and reasoning for scalability of the chosen process.
- Knowledge of Chemical engineering concepts.
- Knowledge of working in SAP system.
- Knowledge of PAT tools.
- Knowledge of Process safety concepts.
- Basic Knowledge of Quality by Design (QbD).
Generic Purpose:
Executing trial, validation and commercial support batches in Kilo lab and Pilot plant for projects , Providing DMF compilation support to the customer, ensuring compliance to regulatory, group directives, quality requirements, safety standards and effective utilization of resources, guiding a team of subordinates to fulfill the organization’s objective, living Group’s Values and Code of Ethics
Submitting project proposals with pilot plant data.
Executing trial, validation & commercial support batches in Kilo lab and Pilot plant for projects
Ensuring Technology absorption and Technology transfer to ANK Chemistry plant.
Manufacturing and supporting for DMF filings in kilo lab and Pilot plant.
Manufacturing of Intermediates and APIs as per protocols
Facilitating Technology transfers and absorptions.
Providing data for statutory licenses to PR&D and manufacturing of APIs
Compliance :Complying with current GMP guidelines.
Complying with local and international norms (Quality/HSE)
Regularly reviewing Pharmacopoeia and regulatory requirement.
Training of self and subordinates on quality and HSE systems.
Safety:Preparing HAZOP, HIRA and other SHARE documents for the process in co-ordination with HSE and quality
Ensuring safety in pilot plant kilo lab during shift operations and shut down operations.
Ensure accident free operations to aim towards zero LTI & first aid cases.
OtherComplying to HSE Requirements
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
Contact
Helvepharm AG