Job Description

REQUIREMENTS

Education / Experience

• Degree in Chemical Engineering OR Graduate in Chemical Engineering (B.TECH) OR Post Graduate in Organic Chemistry OR Post Graduate in Industrial Chemistry
• Experience: 10-15 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).

JOB PURPOSE

Generic
Accountable for providing pilot batches according to established planning, quality and safety standards. Contributes to the validation of generic APIs to support Zentiva generic business and, if the occasion occurs, manages the production of commercial APIs., Ensuring compliance to regulatory, group directives, quality requirements, safety standards and effective utilization of resources, guiding a team of subordinates to fulfill the organization\xe2\x80\x99s objective, living Group\xe2\x80\x99s Values and Code of Ethics.

KEY ACCOUNTABILITIES
Maintaining good mix of skill sets in the team: At least one expert on following area \xe2\x80\x93
Process development, GMP manufacturing, Technology transfer, Scale-up/Process Safety, Process validation, Documentation, Process Engineering CMC activity/GMP:
In agreement with site supply chain department on site and the requirements of the projects, approves raw material sources and ensures timely and quality wise supply of RMs in coordination with site supply chain department,
Ensuring complete GMP documentation (e.g., communication with QA & ARD, documentation during execution of batches, for validation batches.)
Establishing various SOPs e.g. System & operational SOPs and ensuring functional controls and track thereof.
HSE/Safety
In close collaboration with site HSE department, ensures preliminary evaluation of HSE risks on pilot batch processes, implement the safety barriers and requirements on master batch records, makes the necessary decisions in order to operate in safe conditions
In close collaboration with site maintenance department, maintain the pilot plant equipment at a safe, compliant and operating level Providing/Ensuring support:
Sharing plan with shared functions on site (quality, HSE, maintenance, supply chain) and ensuring smooth functioning of plant
Acquiring insight about energies and recharge methodologies
Organising resources in order to provide PP and PE support to PD activities which includes \xe2\x80\x93 Process scalability evaluation, planning of equipment availability, pilot plant and process engineering activities, CAPA support in case of deviation/investigation
Coordinating with PRD & ARD to provide technical/scientific support
Proactive Communication on specific topics:
Physicochemical parameters, specific techniques, equipment, conditions required for API
Ensuring necessary alerts, investigation support in case of deviation & customer complaint analytical in approach
5.2 Accountable for the accuracy of results generated by his team as well as scientific consistency of reports Process Engineering & Technology:
Participation in global forum for brainstorming and ideation.
Getting acquainted and updated with Regulatory compliance & Pharmacopoeia requirement , Quality and HSE system Finance/Accounts/Controlling:
Preparing and Monitoring department budget
Preparing quotation by evaluating the technical information from donor site
External Coordination :
Understanding the need of third party help for functional needs
Evaluating third party and establishing ways of working with them
Leveraging cooperation with academia institutes in the region
Other
Complying to HSE Requirements
Identifying and correcting unsafe conditions or behaviours 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.