Production Head_pharma manufacturing_sh

Experience in a bulk drug / pharmaceutical industry in a relevant section i.e. manufacturing.

Computer knowledge for generating, Reports, Plans, training slides, etc, Building of Team

Well conversant in local language (Kannada, Tulu)

 Strong knowledge of API production and GMP compliance.

 Deep understanding of unit operations (Distillation, Crystallization, Filtration, Drying) and chemical synthesis.

 Expert knowledge of ICH Q7 guidelines and global regulatory requirements.

 Production planning, batch scheduling and process SOPs

 Strong analytical and risk assessment capability.

 Ability to manage multiple products batch run

 Operational reporting, AOPs, OpEx management

1 Production Planning & Operations Management

 Plan and execute Quarterly, Monthly and Weekly production plan as per SNOP ensuring optimum utilization of reactors, centrifuges, and dryers.

 Monitor and improve process yields and cycle times through continuous process monitoring and troubleshooting.

 Manage raw material consumption and utilities (steam, power, chilled water) to minimize variances and production costs.

 Ensuring and maintaining housekeeping in and around the production area

 Handling all types of equipment and the modification in the production

2 Quality & Regulatory Compliance

 Oversee the safe handling of hazardous chemicals, solvents, and exothermic reactions.

 Ensure all processes are conducted within the defined & Safe Operating Envelope& to prevent accidents or chemical releases.

 Work closely with the EHS team to maintain an accident-free workplace and ensure 100% usage of PPE by the shop-floor team

 Handling of deviations, change control and near misses.

 Execution of CAPA’s and implement

 Performing investigation in case of failures

 To make sure that all production deviations are reported and evaluated.

Critical deviations are investigated and conclusion are reported

 Ensuring clean room procedures are followed as per the requirements

3 People Management and Development

 Oversee a multi-shift workforce, ensuring adequate manning and skill distribution across production blocks.

 Collaborate with HR to identify skill gaps and facilitate developmental workshops (technical/ behavioural training) to team including operators.

 Maintain a disciplined and motivated workforce on the shop floor, addressing grievances in coordination with Site HR/ HR Business Partners.

4 Inventory Planning and Despatch Coordination

 Control inventory in co-ordination with SCM.

 Evaluate inventory level on monthly basis to minimize non-moving / dead inventories.

 Evaluate inventory level on monthly basis to minimise /control over production consumables inventories.

 Coordinate with dispatch team of QC, QA, PPIC, Warehouse and logistics for timely delivery after batch allotments for dispatch.

 Ensure the timely delivery of Products

5 Project Management and Reporting

 Prepare equipment occupancy sheets and explore options to introduce new products.

 Create a detailed work plan which identifies activities needed to successfully complete API project.

 Determine the resources (time, equipment, etc) required to complete the project.

 Review the project schedule with CFT team and monitor.

 Execute the project according to the project plan.

 Co-ordinate with QA, QC and PPIC to give the response to the customer technical queries

 Prepare and share daily, weekly report to Site Ops head and cross

functional/ senior leaders.

 Prepare production ORM report of the site. Initiate the scale up meeting

in coordination with CFTs.

6 Track wise, SAP and DMS activity

 Review and approval of BMR’s/BPR’s in Track wise.

 Review and approval of department SOP’s in Track wise.

 Perform activities/transaction’s related to SAP and DMS.

7 Stakeholder Management

 Collaborate/ Work with Site Functional Leaders

 Build relationships with local bodies/ government officials.

 Work with Senior leaders and functional Experts

 Timely response to Customers and regulatory representatives

Skills: tulu,production head,kannada,api,bulk drug,pharma manufacturing,production planning