Production Executive Chemical Engineer / Asst. Manager

Job Description

Key Responsibilities (State the primary duties and tasks of the position)
Main Responsibilities:
➢ Provide relevant inputs to HOD for preparation of Production plan and dispatch commitments.
➢ Inform Stores in case of RM / PM non-availability.
➢ Inform Engg regarding utility & set-up requirements if any.
➢ Prepare Change management format for any modification required and implement the determined controls.
➢ Prepare work allocation / deployment plan & issue work planning. Maintain record in Production log book.
➢ Review the SOP & Raise requisition in oracle / manual on stores for transfer of the required RM / PM.
➢ Monitor processing, DCS and field readings and record the critical steps in Production Log book. Record logs of sample given & results received in batch card and applicable Production Log book.
➢ Highlight deviations immediately to avoid rework / failure and control delay in delivery. Record deviations in the NC / Incidence report.
➢ Ensure In-process, FG sampling and QC clearance.
➢ Transfer of QC pass product for packing as per plan or to the dedicated tanks. Record transfer details in production log book.
➢ Create process orders & confirm them in Oracle system.
➢ Enter all details in Production log book.
➢ Provide packing list to dispatch team during transfer of product for dispatch.
➢ Implement / Maintain HSE practices in all activities.
➢ Maintain daily log for process delays.
➢ implement effective waste management practices

Maintain RM Identification and Traceability

➢ Maintain RM supplier record in Production log book such that batches made from these RM of these suppliers are traceable.
➢ Verify and sign the unloading checklist.
➢ Ensure batch wise identification of packed product to avoid wrong dispatch.
➢ Implement controls to avoid product contamination and material traceability.

Cost saving / effectiveness

➢ Proper utilization of equipment by compliance to the operating instructions.
➢ Ensure equipment calibration prior to use.
➢ Adherence to SOP / Material balance for process effectiveness and reduction of wastes.
➢ Process monitoring to maintain product quality and processing parameters to avoid reprocess, rejections.

Improvements in process and systems for increased effectiveness
➢ HAZOP studies
➢ Risk Impact Assessment studies / Safety reviews.
➢ Review of SOP’s with regard to deviation / process improvements.
➢ Participate in Process and HSE – incident / Deviation investigation and CA / PA and ensure its implementation.
➢ System Audits on quarterly basis.

Training & Awareness on: Process, Operational Controls, HSE

➢ Review of Corrective and preventive actions of all deviations and NC’s for Training need identification.
➢ Performance assessment in terms of skills and competencies & identification of training needs.
➢ Inadequacies identified on day to day interactions.
➢ Technical expertise with regard to improvements determined or changes in the process / technology. Ensure effective production and process controls to meet dispatch schedules.
➢ Coordination with SCP, & Stores for Review of RM / PM availability, priority setting for preparing Production Plan. As required raise immediate indents for short falls. Meeting to be held on fortnightly basis / or in case of changes to plan.
➢ Prepare Production plan – plan to be based on availability of Equipment, RM / PM, preventive checks, utility requests, completion of cleaning activities prior to Batch start- up.
➢ Manpower planning and work allocation.
➢ Total Planning review to be done once in 15 days.
➢ Monitoring of production progress and take appropriate actions to ensure compliance with SOP. Process details to be maintained in batch card and actions taken in the shift log book.
➢ Review the shift log-book to capture abnormalities (if any) and take appropriate CA/ PA.
➢ Fortnightly Review of Dispatch plan to note deviations if any and do necessary corrections.

Education •
A graduate/ Post graduate with at least eighteen months practical experience after the graduation in the manufacture of drugs (APIs) in Indian State FDA Licensed Premises; or a graduate in Science (Chemistry as a principal subject), Chemical Engineering, •The candidate must be FDA Approved Manufacturing Chemist/Staff for Bulk drug Manufacturing

Work Experience 10 to 12 Yrs in Production dept of Chemical / Petrochemical / Active Pharma Industry.

Skills
•Maintaining good manufacturing practices and conditions suitable for production of chemical products
•Face FDA Inspections and other Audits and able to act as Representative/Lead auditee from Production Department during FDA
Inspections/Audits/Customer GMP Audits
•Reviewing documentation and ensuring all in-process checks are carried out as per the standard operating process
•Developing standard operating procedures to improve efficiency
•Preparing directions for Junior Chemists/Production Operators for each step in the production process Knowledge
•In-depth understanding and knowledge of good manufacturing practices pertaining to Pharmaceutical API, including process validation
•Knowledge of documentation as per GMP and QMS guidelines