Zentiva

Produces branded generic pharmaceuticals in Europe

Production Manager - Chemistry

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours

Full-timeAnkleshwar, Gujarat, IndiaNo salary listedIn-person

About the Job

Requirements

A degree in Chemical Engineering, a B.Tech in Chemical Engineering, or postgraduate/Ph.D. study in Chemistry.
10–20 years of experience.
Leadership, planning, organizing, decision-making, people management, manpower planning, interpersonal and communication skills, and ability to drive continuous improvement.
Sound technical knowledge of plants and processes.
Maintain balanced skill sets across production teams, including expertise in process development, GMP manufacturing, technology transfer, scale-up/process safety, process validation, documentation, and process engineering.

Responsibilities

Provide commercial batches according to established planning, quality, and safety standards; contribute to validation of generic active pharmaceutical ingredients (APIs) and manage commercial API production when required.
Ensure compliance with regulatory and group directives, quality requirements, safety standards, and effective resource utilization while guiding subordinates in support of organizational objectives and the Group’s values and code of ethics.
Prepare, implement, and achieve production activities for APIs and intermediates in accordance with quality and health, safety, and environment (HSE) standards; ensure quality and safety practices are followed by team members.
Coordinate with relevant teams to achieve standard product costs and good manufacturing practice (GMP) and HSE compliance; monitor plant utilities, waste, bottleneck-equipment occupancy, and other operational needs with support functions.
Approve raw-material sources and ensure timely, quality-compliant supply in coordination with site supply chain, in accordance with project requirements.
Ensure complete GMP documentation, including communication with quality assurance (QA) and quality control (QC) and documentation during batch execution and validation batches.
Establish system and operational standard operating procedures (SOPs), ensure functional controls, and track their implementation.
Implement corporate guidelines, regulatory directives, and local FDA requirements; ensure team compliance.
Ensure deviations and change controls are assessed within specified timeframes; report production deviations promptly, investigate root causes, and implement corrective and preventive actions (CAPAs) for critical deviations.
Prepare for internal and external audits; prepare, review, approve, and distribute production documents in accordance with QA, HSE, and legal requirements.
Produce APIs and intermediates in accordance with approved batch manufacturing records (BMRs), master formula records (MFRs), and SOPs; review production batch records to assess overall performance.
Maintain facility hygiene and cleanliness, ensure personnel follow SOPs and maintain records, and review validation protocols and reports.
Evaluate proposed changes to products, processes, and equipment; ensure facility modifications, equipment changes, and new plant activities undergo change control and qualification before production use.
Work with site HSE to evaluate risks in commercial batch processes, implement safety barriers and requirements in master batch records, and make decisions necessary for safe operations.
Work with site maintenance to keep plant equipment safe, compliant, and operational; implement and follow Group HSE guidelines and regulatory requirements.
Lead, guide, and maintain departmental environmental management and environmental, health, and safety systems; lead process-risk analysis and establish mitigation plans.
Maintain health, safety, and environmental management systems; identify and correct unsafe acts, conditions, and behaviors, and promptly report potentially hazardous situations.
Share plans with site quality, HSE, maintenance, and supply-chain functions and ensure smooth plant operations.
Acquire insight into energy use and recharge methodologies.
Organize resources to provide plant and process engineering support for commercial activities, including scalability evaluation, equipment-availability planning, plant and process engineering, and CAPA support during deviations or investigations.
Coordinate with manufacturing science and technology (MST) and QC to provide technical and scientific support.
Address API physicochemical parameters and the techniques, equipment, and conditions required for production.
Provide alerts and investigation support for deviations and customer complaints using analytical approaches; ensure the accuracy of team results and scientific consistency of reports.
Identify, analyze, and resolve daily process, equipment, and manpower issues; improve API and intermediate manufacturing processes with the process development team.
Participate in global brainstorming and ideation forums; stay updated on regulatory compliance, pharmacopoeia requirements, quality systems, and HSE systems.
Prepare and monitor the department budget and prepare quotations by evaluating technical information from donor sites.
Identify functional needs for third-party support, evaluate third parties, establish ways of working with them, and develop cooperation with regional academic institutes.
Prepare standard costs and budgets; monitor and control revenue budgets, material utilization, energy consumption, and efficient material, machine, and labor utilization.
Participate in and prepare capital budgets for technical upgrades and productivity improvements.
Ensure team members are trained before participating in manufacturing activities and provide refresher training as needed.
Develop successors and subordinates to support smooth business operations.
Stagger team holidays and weekly days off to maintain operations across all three shifts.
Maintain good relationships with operative staff, understand their concerns, and propose welfare actions.
Ensure effective use of SAP HANA for business purposes and leverage programmable logic controllers (PLCs) in manufacturing operations.
Carry out other assignments or projects as instructed by the department head to meet organizational objectives and priorities.

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.
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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
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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.
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About the Company

Zentiva

Produces branded generic pharmaceuticals in Europe

Zentiva makes branded generic medicines for European markets. Its products are off-patent drugs reformulated and marketed under Zentiva’s brands, delivering the same active ingredients and dosage as original medicines at lower prices. It differentiates itself through a long history as an independent platform under private equity, with a growth strategy built on acquiring brands to expand its European footprint. The goal is to become a leading European branded generics platform and improve access to affordable medicines across its markets.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Prague, Czechia
Founded: 2003

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