Section Head - Production

Job Title: Mfg. Section Head

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs)

Reports To: Mfg. Department Head

Salary Range: $83,200 - $104,000

Control manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and manufacturing targets in time.

• Monitor and control planned production
  • Review planned production vs. actual production daily and control the production activity of the plant as per the schedule
  • Prepare production schedules for the block and ensure adherence to the schedules
  • Ensure availability of raw materials, reagents and solvents during all shifts by verifying it with the forecasts
  • Ensure execution of new product & product transfer by performing gap analysis to meet market requirements
  • Review in-process analysis on daily basis to enhance the quality of final product
  • Monitor unit operations and processes to avoid failures
  • Ensure seamless communication and knowledge transfer of product in line across shifts for continuous production by participating in shift performance dialogue
• Ensure maintenance is carried out as per standards
  • Close maintenance issues by reviewing processes to meet production targets by coordinating with Engineering
  • Optimise the utilisation of manufacturing consumables as per the budgets to reduce overhead cost
  • Conduct the daily cross functional AET meeting to continuously improve Yield, Solvent recovery, reduce OOS, OOT and complaints.
  • Evaluate the requirement and ensure the availability of critical spare and consumables for the machines to avoid time loss during any machine breakdown
• Prepare, review and update GMP documents
  • Prepare the facility and rectify issues related to facility management and documentation for audit readiness
  • Handle investigations, OOS, OOT, change controls, deviation & CAPA in the block
  • Ensure online documentation for any non-conformance to meet GMP by performing surprise checks
  • Prepare and review the qualification, validation and other documents to maintain GMP
  • Participate in the internal and external audits to assure system control
  • Review new batch manufacturing records, SOPs, APQR for correctness and completeness and provide recommendations
• Ensure adequate and trained manpower availability across shifts
  • Ensure effective utilisation of manpower in each shift by understanding workload and requirement to get desired production output
  • Plan and impart training on SOPs, new guidelines and policies to for achieve zero non-conformance
• Monitor employee and workplace safety
  • Ensure all operations are performed as per safety norms to avoid accidents in plant
  • Ensure availability and maintenance of PPEs by coordinating with HSE department for requirements and shift schedule
  • Conduct safety training by coordinating with HSE to promote a culture of safe working
• Implement manufacturing excellence practices for continuous improvement
  • Ensure maximum utilization of the machine in a shift by reviewing reports during shift performance dialogue
  • Review the OOE data and monitor the PDCA system to minimize the losses
  • Track monthly change over time of machine to sustain the baseline
  • Prepare the plans for utilization of bottleneck machines to reduce the time loss
  • Monitor the yield of runner products to ensure yield above baseline

• Meeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planning
• Keeping up with production schedule during facility renovation and equipment upgrade
• Utilisation of capacity as per the production plan due to volatile demand. Overcome by rescheduling of plans
• More lead time for approval of regulatory documents by internal and external stakeholder Overcome by regular follow ups
• Unavailability of machine spares items because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare to be maintain all the time at stores for all identified machines.
• Long cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stake holder i.e. RA, R&D, LCM team and CQA, which can be overcome by defining the timelines for each stakeholder
• Issues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc. Overcome by taking investigation and CAPA from the supplier

• Internal
  • Quality Assurance/Control for scheduling of batches, issues in product (Daily)
  • Engineering & Utility for system related queries (Daily)
  • Technical Support for troubleshooting in products (Case Basis)
  • Technology Transfer for support in new products (Project Basis)
  • Stores and Warehouse for RM/PM related activities (Daily)
  • EHS for safety rounds and PPEs (Daily)
  • Capacity planning, R&D, RA other manufacturing unit for Multiple formula harmonization and batch size optimization (Case basis).
  • QA and CQA for preparation and implementation of SOP'S (Case…