Section Head - Production Job Fall River area,Massachusetts USA,Manufacturing / 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

Purpose

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.

Key Accountabilities

Monitor and control planned production: daily activity review as per production plan to meet production targets and quality standards

Ensure availability of raw materials, reagents and solvents during all shifts by verifying with 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.

Close maintenance issues by reviewing processes to meet production targets by coordinating with Engineering.

Optimise 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 requirement and ensure availability of critical spare and consumables for machines to avoid time loss during any machine breakdown.

Prepare, review and update GMP documents to meet regulatory compliance and quality of product.

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.

Participate in internal and external audits to assure system control.

Review new batch manufacturing records, SOPs, APQR for correctness 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.

Plan and impart training on SOPs, new guidelines and policies to achieve zero non-conformance.

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.

Conduct safety training by coordinating with HSE to promote a culture of safe working.

Implement manufacturing excellence practices for continuous improvement.

Monitor the yield of runner products to ensure yield above baseline.

Review OOE data and monitor PDCA system to minimize the losses.

Prepare plans for utilisation of bottleneck machines to reduce time loss.

Provide daily monitoring of key performance indicators and generate shift reports.

Major Challenges

Meeting priority demands during clashing equipment requirement in multiproduct facility.
Keeping up with production schedule during facility renovation and equipment upgrade.
Utilising capacity as per the production plan due to volatile demand.
Long lead time for approval of regulatory documents.
Unavailability of machine spares items due to limited budget.
Long cycle time for variation approval or modification in batch manufacturing record.
Issues in Quality of Raw Material such as lumps formation and foreign material.

Key Interactions

Internal:
Quality Assurance/Control, Engineering & Utility, Technical Support, Technology Transfer, Stores and Warehouse, EHS, Capacity planning, R&D, RA, QA and CQA, IT, Central SCADA Team.
External:
Original equipment manufacturers, External Auditors, Equipment tooling suppliers, Maintenance contractor, Civil contractor.

Key Decisions

Scheduling of production batch.
Utilisation of manufacturing consumables.
In-process checks.
Manpower scheduling shift wise as per production plan.
Deviation and implementation of CAPAs.
Modification in plant and equipment.
Identify products where batch size can be increased to enhance plant capacity.
Develop cost‑effective alternate vendors for tools and equipment accessories.
Modification in qualification document.

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