Manager Production, Chemistry
Zentiva · Ankleshwar
JOB TITLE
Manager, Production, Chemistry
REQUIREMENTS
Education / Experience
- Degree in Chemical Engineering OR Graduate in Chemical Engineering (B.TECH) OR Post Graduate/Ph. D. in Chemistry
- Experience: 10--20 years
Technical skills &
Competencies / Language
- Leadership
- Planning, organizing and decision making
- People management and Manpower Planning
- Interpersonal skills and Communication
- Ability for continuous improvement
- Sound technical knowledge of plants and processes
- Maintain balanced skill sets across production teams
JOB PURPOSE
Generic
Accountable for providing commercial 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’s objective, living Group’s Values and Code of Ethics.
Prepare, implement and achieve production activities of APIs/intermediates with Quality and HSE standards. Ensure quality first and safety always followed by each and every team member. Coordinate effectively to ensure standard product cost, GMP and HSE compliance are achieved by team. Collaborate effectively with support functions to ensure smooth production activities by daily monitoring of plant utilities, wastes, occupancy of bottleneck equipment, etc while living with Group’s Values.
KEY ACCOUNTABILITIES
Maintaining good mix of skill sets in the team: At least one expert on following area –
- Process development, GMP manufacturing, Technology transfer, Scale-up/Process Safety, Process validation, Documentation, Process Engineering
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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 & QC, documentation during execution of batches, for validation batches.)
- Establishing various SOPs e.g. System & operational SOPs and ensuring functional controls and track thereof.
- Ensure corporate guidelines, regulatory directives, and local FDA requirements are implemented and followed by team.
- Ensure deviation and change control procedures are assessed within specified timeframe.
- Prepare for Internal and External audits.
- Prepare, review, approve and distribute all documents required for production of APIs or intermediates as per QA, HSE and legal requirements.
- Produce APIs or intermediates by following approved BMRs, MFRs and SOPs.
- Review all production batch records to understand overall performance.
- Ensure all production deviation(s) is/are reported as early as possible and investigated to real find root cause(s). Ensure the implementation of CAPAs for all critical deviations.
- Ensure production facilities hygiene by cleaning, disinfecting, etc as per SOPs.
- Maintain the plant premises neat and clean.
- Ensure the SOPs are followed by plant personnel and records are maintained.
- Ensure validation protocols and reports are meticulously reviewed.
- Evaluate the changes proposed for products, processes and equipment.
- Ensure the new/old facility modification or equipment or any new activity in plant is routed through a change control and qualified before using for production.
HSE/Safety
- In close collaboration with site HSE department, ensures preliminary evaluation of HSE risks on commercial 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 plant equipment at a safe, compliant and operating level
- Participate, implement, and adhere to Group HSE guidelines and regulatory requirements.
- Lead, guide and maintain departmental EMS and EHS system.
- Lead process-risk analysis for manufacturing operations to identify proactively what could go wrong and have mitigation plan for it.
- Maintain the health, safety and environmental management systems.
- Identify and correct unsafe acts/conditions or behaviors and promptly report the potentially hazardous situation(s).
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 Plant and Process engineering support to Commercial activities which includes – Process scalability evaluation, planning of equipment availability, plant and process engineering activities, CAPA support in case of deviation/investigation
- Coordinating with MST and QC to provide technical/scientific support
Proactiveness 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
- Accountable for the accuracy of results generated by his team as well as scientific consistency of reports.
- Proactively identify, analyze and resolve issues related with processes, equipment and manpower on daily basis.
- Improve the current manufacturing processes of APIs/intermediates with the help of process development team.
- undefined
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
- undefine
Cost Control
- Prepare standard costs and budgets, monitor and control revenue budgets, material utilization, energy consumption and optimum materials, machine and labor utilization.
- Participate and prepare the capital budget for technical up gradation and productivity improvements.
People management
- Ensure team is fully trained before participating in manufacturing activities. Based on requirement, provide refresher trainings
- Develop your successor and subordinates to ensure the smooth business operations.
- Ensure the staggering holidays/weekly offs for team members to continue operations in all three shifts.
- Maintain good relationships with operative staff. Sympathize and understand their concerns and propose actions for their welfare.
Digitalization
- Ensure the full utilization of SAP-HANA for business purpose.
- Leverage PLC for manufacturing operations.
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.
- undefined