Production Executive | Zydus | Ahmedabad

Job Description

Roles and Responsibilities:

• Review of Master Documents
• Review of Logbooks, Other documents/records related to the department Review of Executed Batch Records (Manufacturing & Packaging)
• Review of Technology transfer documents, Cleaning Validation and process validation Protocols and Reports, and equipment /AHU qualification documents
• Review of investigation Reports related to Market Complaints, Deviation, OOS, OOT, change control and CAPA reports, Annual product review, Trend data, and Site master file.

• To clean the area
• To record the housekeeping records
• To enter the area as per the respective SOP
• Information to the Operators for attending training programs as per the schedules provided. Attend training sessions as per TNI.
• Reading Standard Operating Procedures (SOPs) to understand and perform the activities as per Good Manufacturing Practices and Safety norms.
• Maintaining Training records.
• Take and give charge of the plant, surrounding area, running batches/Activities, Documents, Raw
• Material, Solvents, Equipment Status, Utilities, Housekeeping from previous shift person/reliever, and proceed further.
• Daily Activities performance and recording as per SOP like Balance verification, Cleaning & Sanitation, Differential pressure, temperature, humidity, and maintaining of pH of the Scrubber with the help of the Plant Operator & Helper.
• Proper segregation & storage of effluent at the plant level and transfer it to identified area.
• Proper segregation & storage of liquid waste at the plant level and transfer it to identified area. Maintaining of equipment status boards of each piece of equipment as per current status.
• Assigning work to the permanent and contract workmen. Work planning for the shift/day as per the priorities.
• Activities which carried out should be recorded in the BMR /ECR / Equipment usage log or relevant documents.
• Prior to starting the activity/operation, cross-checking/verification of Raw Material quantities, Batch No / Lot number, physical appearance, equipment cleanliness, functionality and Instruments, and availability of utilities.

• If any parameter departs from the standard during operation/execution, then initiating deviation and its recording in the relevant document and in the Quality System.
• Actively participate in the Investigation of deviations, OOS, OOT, or any safety event and implementation of Corrective Actions and Preventive Actions.
• Preparation of Test Requisition slips for in-process, cleaning samples, and Complete Analysis.
• Preparation of label request and complete analysis request for sampling and packing of Intermediates / APIs.
• Issuance, Check, and Ensure that Raw material, packaging material, and cleaning material is received as per the requirement mentioned in the material requisition slip from the warehouse and keep it to the designated area in the plant.
• Issuance and archival of documents on time.
• Documents like BMR / ECR review online and after completion of activity and submission to QA. Maintaining plant and its surrounding area cleaning in every shift & every day.
• Keep the BMR, ECR, Equipment Usage log book updated, and other documents online near the relevant equipment/place.
• To ensure timely preventive / breakdown maintenance of equipment.

• To ensure self and operators adherence to the use of PPEs as per safety norms. Reporting of Near misses, and incidents that occurred in the shifts.
• Adherences with the EHS improvement plan to conduct safety talk, Tool Box talks, etc. on the shop floor. Awareness & compliance of cGMP, Safety, SAP etc.

• Focus for improvement in day to day activity.
• Awareness about Energy Conservation like Electricity, water, manpower etc. To inform mandatory items required for the facility.
• Coordination with interfacing departments like Engineering, QC, QA, Safety, Warehouse, etc. to create discipline in the plant w.r.t. Regularity, leave management, shift re-arrangement, safety, and GMP.
• Batch Manufacturing, Equipment cleaning Record preparation, and review. SOP preparation, review, and training.
• Execution and Monitoring of validation and qualification activity.
• Participate actively in internal Audit, customer audit, CAC audit, and GPCB audit as per schedule. Performing HAZOP for new/existing products as per requirement.
• Handling of SAP system.
• Information to the Operators for attending training programs as per the schedules provided. Attend training sessions as per TNI.
• Reading Standard Operating Procedures (SOPs) to understand and perform the activities as per Good Manufacturing Practices and Safety norms.
• Maintaining Training records.
• Take and give charge of the plant, surrounding area, running batches/Activities, Documents, Raw materials, Solvents, Equipment Status, Utilities, and Housekeeping from the previous shift person/reliever and proceed further.
• Daily Activities performance and recording as per SOP like Balance verification, Cleaning & Sanitation, Differential pressure, temperature, humidity, and maintaining of pH of the Scrubber with the help of the Plant Operator & Helper.
• Proper segregation & storage of effluent at the plant level and transfer it to identified area.
• Proper segregation & storage of liquid waste at the plant level and transfer it to identified area. Maintaining of equipment status boards of each piece of equipment as per current status.

• Assigning work to the permanent and contract workmen. Work planning for the shift/day as per the priorities.
• Activities which carried out should be recorded in the BMR /ECR / Equipment usage log or relevant documents.
• Prior to starting the activity/operation, cross-checking/verification of Raw Material quantities, Batch No / Lot number, physical appearance, equipment cleanliness, functionality and Instruments, and availability of utilities.
• If any parameter departs from the standard during operation/execution, then initiating deviation and its recording in the relevant document and in the Quality System.
• Actively participate in the Investigation of deviations, OOS, OOT, or any safety event and implementation of Corrective Actions and Preventive Actions.
• Preparation of Test Requisition slips for in-process, cleaning samples, and Complete Analysis.
• Preparation of label request and complete analysis request for sampling and packing of Intermediates / APIs.
• Issuance, Check, and Ensure that Raw material, packaging material, and cleaning material is received as per the requirement mentioned in the material requisition slip from the warehouse and keep it to the designated area in the plant.
• Issuance and archival of documents on time.
• Documents like BMR / ECR review online and after completion of activity and submission to QA. Maintaining plant and its surrounding area cleaning in every shift & every day.
• Keep the BMR, ECR, Equipment Usage log book updated, and other documents online near the relevant equipment/place.
• To ensure timely preventive / breakdown maintenance of equipment.
• To ensure self and operators adherence to the use of PPEs as per safety norms. Reporting of Near misses, and incidents that occurred in the shifts.
• Adherence to the EHS improvement plan to conduct safety talks, Tool Box talks, etc. on the shop floor. Awareness & compliance of cGMP, Safety, SAP, etc.

• Focus on improvement in day-to-day activity.
• Awareness about Energy Conservation like Electricity, water, manpower, etc. To inform mandatory items required for the facility.
• Coordination with interfacing departments like Engineering, QC, QA, Safety, Warehouse, etc. to create discipline in the plant w.r.t. Regularity, leave management, shift re-arrangement, safety, and GMP.
• Batch Manufacturing, Equipment cleaning Record preparation, and review. SOP preparation, review, and training.
• Execution and Monitoring of validation and qualification activity.
• Participate actively in internal Audit, customer audit, CAC audit, and GPCB audit as per schedule.
• Performing HAZOP for new/existing products as per requirement. Handling of SAP system.

Desire Candidate Profile:

Qualification: B.Tech/B.E. in Bio-Chemistry/Bio-Technology, Chemical

Experience: 3-5 Years

CTC: 2.4-4.00 L