Head - Production

Division

Department

Sub Department 1

Job Purpose

Manage, control and upgrade the manufacturing activities in production area with optimum utilization of resources in order to ensure smooth operations in line with safety & cGMP to meet production targets, and produce quality product within timelines.

Key Accountabilities (1/6)

Review and monitor monthly production plan for area by considering product demand and available resources to facilitate smooth operations and meet production targets

• Review the available resources, production requirements & forecasts of a block as per production plan and monitor its implementation
• Liaise with QC for release of analysis of batches / input material and with warehouse for RM/PM availability
• Liaise with quality assurance to get the approved documents triggered through QMS

Monitor the daily production operations to ensure efficient operations and  delivery as per business need while ensuring compliance to regulatory and statutory norms

• Review of planned production v/s actual production  of the block as per production schedule
• Maintain operational efficiency by guiding the team to resolve issues and drive improvements
• Identify the bottlenecks in the course of production in a block and mitigate the same
• Review documents like gap analysis, BMR, BPR and FMECA etc.

Key Accountabilities (2/6)

Monitor all activities to be in adherence to HSE standards and statutory compliance in a block through periodic reviews to avoid accidents & create a safe working environment

• Review safety systems and procedures followed in the plant in coordination with HSE department
• Evaluate and mitigate potential hazards in department by tracking all incidents/accidents and implementing CAPAs
• Ensure safety training completion in department by coordinating with HSE department

Key Accountabilities (3/6)

Maintain the integrity of online documentation & compliance to cGMP by tracking the systems and controls at unit to meet regulatory and customer requirements and deliver quality product

• Review and approve GMP documents and maintain integrity of documentations during regulatory and customer audits
• Investigate failures/deviations, market complaints and implement CAPAs
• Monitor the execution of appropriate validation, qualification and calibration of equipment and apparatus are performed and recorded by conducting review meetings
• Review the change controls and communicate their impact on documents and facility to QA/QC, engineering, etc.
• Ensure training is imparted on documentations, critical process parameters, changes being made & failures or deviations to adhere to cGMP requirements
• Identify all the failures w.r.t. equipment, facility, manufacturing process including pertinent assumptions and identify the potential risk to have adequate control measures
• Participate in vendor audits to ensure supply of material as per required quality.
• Participate in self-inspections and internal audits to review the documents and systems against predefined standards.
• Review the APQR data to identify and fix the process variables to control the process.
• Ensure compliance of the action plans generated in QMR w.r.t. cGMP, safety and process improvements

Key Accountabilities (4/6)

Monitor the maintenance of machines as per standards to avoid uncertainty in operation  and adherence to approved budget to reduce overheads

• Review processes to close maintenance issues  by coordinating with engineering department
• Track and optimise the utilisation of manufacturing consumables
• Track and optimise the manpower resources used for smooth execution of departmental activities
• Ensure the facility upkeep and rectify issues related to facility management and documentation for audit readiness
• Ensure the procurement and development of imported machine spares through local vendors using technicalexpertise and maintaining adequate stock to eliminate downtime

Key Accountabilities (5/6)

Drive continuous improvements and ensure reduction in process cycle time through unit operational studies to reduce production cost and make the capacity available without CAPEX

• Conduct unit operational study to find improvement areas and implement new development projects

• Drive continuous automation of processes through identification, review & implementation of new technology & software.
• Review the reject analysis and target the elimination of variables in the process resulting in yield & efficiency improvement.
• Propose and execute brown field projects for capacity enhancement

Key Accountabilities (6/6)

Monitor the implementation of plan set for completion of site transfer / IPD projects to ensure on-time launch

• Review documents like gap analysis, BMR, BPR and FMECA etc. in coordination with Tech Transfer and monitor production of batches
• Execute AVD while adhering to regulatory requirements to avoid complexity during commercialization
• Provide Tech Transfer training to employees with the help of Tech Transfer department

Major Challenges

• Meeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planning and prioritization
• Meeting production targets while managing high level of attrition in department. Overcome by multiskilling and talent development
• Inadequate utilisation of capacity as per the production plan due to volatile demand. Overcome by maintaining 3M planner and forward planning

Key Interactions (1/2)

• Quality Assurance/Control for scheduling of batches, issues in product , release of input materials (Daily)
• Engineering & Utility for system related queries (Daily)
• Formulation R&D for CC approvals, troubleshooting products, etc. (Case Basis)
• Purchase for indenting materials (Fortnightly)
• Formulation Tech Transfer for support in new products, CC approvals (Project Basis)
• Stores and Warehouse for RM/PM related activities (Daily)
• HSE for safety rounds and PPEs, destruction of accessories (Daily)
• Planning  for daily plan, availability of resources, change in plans (Daily)
• Accounts for monitoring and costing / vendor payments (Weekly)

Key Interactions (2/2)

• Labour Contractor for any workmen related queries (Monthly)
• Maintenance Contractor for any machine repairs (Weekly)
• External Auditors  during facility audits (as per schedule)
• Suppliers / Vendors for quality related issues communication and improvement (Case Basis)

Dimensions (1/2)

• Operating Expenditure Budget (OPEX) : INR 100.00 lacs per year
• Direct Reports : 8
• Team Size : 176
• Volume of FP manufactured : 1200mn (Tablets)
• No. of brownfield projects handled : 2 per year
• No. of IPD products handled : 8 per year
• No. of US launches handled : 2 per year
• No. of site transfer products managed : 8 per year
• Approx. number of products manufactured : 25-30 (as per 2015-16 data)
• Achieve internal OTIF more than 90%
• Achieve Zero reportable accidents / incidences during manufacturing. Zero
• Achieve set target for batch failure reduction : NMT 2
• Achieve 0% errors in online documentation
• Meet 100% compliance to SOP and safety regulations.
• Meet target set for cost reduction, time cycle, yield improvement

Dimensions (2/2)

Key Decisions (1/2)

• Scheduling of production batch
• Utilisation of manufacturing consumables
• Mapping of new equipment for new products

Key Decisions (2/2)

• Utilisation of equipment & process as per the QMS (To Unit Head)
• Deviation and implementation of CAPAs to Unit Head
• Modification in department and equipment to Unit Head & Unit Engineering Head
• Usages of alternate vendor for RM, consumables & machine spares to Unit Head Formula and process simplification and harmonization to Unit Head

Education Qualification

Graduate in pharmacy

Relevant Work Experience

• 12-14 years of experience with 5-6 years of experience in formulation manufacturing at middle management level  
• Understanding of formulation manufacturing operations, safety & cGMP systems, Site transfer, Machine procurement and qualification related to brown field projects