Zentiva is a Pan-European Platform developing, manufacturing and providing high-quality and affordable medicines to more than 100 million people in Europe.
Assistant Manager II – Production, Chemsitry
Ankleshwar, Gujarat, India
Education / Experience
- M. Sc. (Organic / Industrial Chemistry) or B. Sc. (Tech) or B.E. Chemical
- 9 -11 year experience of API Plant
Technical Skills & Competencies / Language
- Knowledge of current plant processes and technological updates.
- Knowledge of Production data generation and analysis
- Awareness of Basic cGMP, regulatory and HSE requirements
- Sense of urgency , Maturity, Pro activeness
- Communication , Presentation and Interpersonal skills
- Coordination
- Influencing and decision-making
Generic
Purpose of this job is to Supervise, co-ordinate and organize API manufacturing activities in shifts adhering to cGMP / HSE norms/ standards with optimum utilization of man / machines and facilities in compliance with regulatory requirements, living Group’s Values and Code of Ethics
Key Accountabilities
Specific
Preparing Standard Operating Procedure (SOP) on operations related to the manufacturing process as per MFR, BMR and ECR, Equipment Qualification(IQ / OQ/PQ )documents etc.
Assess, rationalize and Initiate change control requirement for manufacturing related modifications, new projects, new proposals.
Ensure necessary investigation and corrective/ preventive actions for deviations occurring during manufacturing activities.
Preparing and executing the required documents for plant shut down and plant start up as per available SOP.
Organizing and allocating manpower in shift, based on present strength and process requirement and priority to ensure planned output and productivity.
Supervising / ensuring performance of activities as per the SOPs, adhering to GMP /HSE guidelines and also ensuring completeness of BMR and all cross reference documents in all respects to maintain on line and audit readiness.
Imparting on the job and classroom training to subordinates on SOP / GMP / HSE / Process / Energy conservation and revised documents.
Ensuring adherence to Quality & HSE systems in the area under control.
Coordinating on need basis with cross functional departments in order to ensure smooth functioning of the plant.
Maintaining good housekeeping in the plant. Ensuring adequate inventory of housekeeping material, inspection, and instruction to housekeeping supervisor and follow up.
General
Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations in line with the established reporting system.
Coordinating With
- Engineering for small modification required for process (e.g. extension of flexible pipe, electric connection etc), day to day break down maintenance, job instructions to technicians in shift, suggestion / discussion for plant modification and communicating to plant Manager in required cases
- Planning and issuance and transfer of material to Chemical ware house based on daily requirement as per production schedule.
- Quality Operation for IPC samples, analysis results follow up, discussions and action on deviations, regular inputs to IPC about product at various stages for preparation of testing requirement, follow up on status.
- HSE for work permit approval, incident / accident reporting, report on unsafe condition, ETP related operation and issues, effluent disposal, hazardous waste, charcoal and residue incineration issues, data on EHS as required from time to time, new experiment for effluent disposal with the help of WWTP, EHS guidelines / local statutory compliances.
- Plant Manager / Assistant Managers for Deviation / Observation / incidence pertaining to Quality, HSE and Production where required for plant presence.