Ankleshwar, Gujarat, India · On-site
JOB TITLE - Executive : Production, Chemistry JOB PURPOSE Generic Purpose of this job is to co-ordinate and organize API manufacturing activities in shifts adhering to cGMP / HSE norms/ standards with optimum utilization…
Skills: API Manufacturing, cGMP, HSE Standards, SOP Preparation, Equipment Qualification
Ankleshwar, Gujarat, India · On-site
JOB TITLE Senior Executive I - Operations Excellence Specialist REQUIREMENTS Education / Experience Education: Diploma / Graduate/ Post Graduate in Pharmacy Experience: At least 1 to 5 years in the Pharmaceutical plant. …
Skills: Lean Methodology, KPI Reporting, Data Analysis, Process Improvement, Cost Reduction
Ankleshwar, Gujarat, India · On-site
JOB TITLE Assistant Manager I, Quality Compliance JOB PURPOSE Generic Implement Quality Compliance & Regulatory Affairs activities at Ankleshwar site adhering to Zentiva Corporate Quality Policies, Regulatory and HSE gui…
Skills: Quality Compliance, Regulatory Affairs, GMP, CAPA Management, CMC Documentation
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Coordinate and organize API manufacturing activities in shifts while adhering to cGMP and HSE standards. Responsible for preparing SOPs, managing manpower, and ensuring audit readiness through rigorous documentation and process supervision.
Requires a degree in Organic/Industrial Chemistry, Chemical Engineering, or B.Sc. (Tech) with 1 to 5 years of experience in an API plant. Must possess technical knowledge of plant processes, regulatory requirements, and proficiency in SAP and PLC/SCADA systems.
JOB PURPOSE
Educational qualification/Experience
KEY ACCOUNTABILITIES
SpecificPreparing 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.
Material management and SAP transactions especially for prohibition substances.
Execution of Hydrogenation processes and safe handling of pyrophoric catalyst.
Operation through PLC / SCADA based systems for API manufacturing.
GeneralIdentifying 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.
At Zentiva, we provide health and wellbeing for all generations
Zentiva provides health and wellbeing for all generations, with focus on developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 40 countries across Europe and beyond. Zentiva has four manufacturing sites and a broad network of external manufacturing partners. Zentiva employs more than 5,400 unique talents, bonded together by a commitment to the people who depend on our products every day. Visit us at www.zentiva.com. Data protection: It’s not just a checkbox – it’s our commitment! Please visit our Privacy Notice https://www.zentiva.com/gdpr/privacy-notice
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