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 by daily activity review as per production plan to meet production 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 a 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 realize optimum utilisation of manufacturing consumables.
• 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 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 for 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 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.
• Keeping up with production schedule during facility renovation and equipment upgrade.
• Utilisation of capacity as per the production plan due to volatile demand.
• More lead time for approval of regulatory documents by internal and external stakeholder.
• Unavailability of machine spares items because of limited budget.
• Long cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stakeholder.
• Issues in Quality of Raw Material such as lumps formation, presence of foreign material.

Internal

External

• 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 for manufacturing unit harmonization and batch size optimization (Case basis)
• QA and CQA for preparation and implementation of SOP's (Case Basis)
• IT for computerised system validation (Case Basis)
• Central SCADA Team for Real time process data…