Section Head - Packaging

Job Title: Pkg. 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: Pkg. 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 packaging targets in time.

• Monitor and control planned production by daily activity review as per packaging plan to meet packaging targets and quality standards
  • 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 to realise optimum utilisation of manufacturing consumables
  • Close maintenance issues by reviewing processes to meet production targets by coordinating with Engineering
  • Optimise the utilisation of packaging 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 to meet regulatory compliance and quality of product
  • 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 to ensure production continuity
  • 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 achieve zero non‑conformance
• Monitor employee and workplace safety to maintain safe environment
  • 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 packaging excellence practices for continuous improvement
  • Ensure maximum utilisation 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 utilisation 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 stakeholders. Overcome by regular follow ups
• Unavailability of machine spares items because of limited budget. Overcome by…