Section Head - Packaging

Job Title: Pkg. Section Head

FLSA Classification: Professional, Exempt

Work Location: Fall River, MA

Work Hours: 8:30 AM – 5:00 PM (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 are carried out according to cGMP and safety requirements, and to meet quality and packaging targets on time.

• Monitor and control planned production by reviewing daily activity against the packaging plan to meet targets and quality standards.
• Review planned versus actual production daily and ensure alignment with the plant schedule.
• Prepare production schedules for the block and ensure adherence.
• Ensure availability of raw materials, reagents and solvents during all shifts by verifying forecasts.
• Oversee new product introduction and product transfers by performing gap analyses to meet market requirements.
• Review in‑process analysis daily to enhance final product quality.
• Monitor unit operations and processes to avoid failures.
• Ensure seamless communication and knowledge transfer of product processes across shifts through shift‑performance dialogue.
• Coordinate with Engineering to close maintenance issues and meet production targets.
• Optimize utilization of packaging consumables to reduce overhead cost.
• Conduct the daily cross‑functional AET meeting to continuously improve yield, solvent recovery, reduce OOS, OOT and complaints.
• Ensure availability of critical spares and consumables for machines to prevent downtime.
• Prepare, review and update GMP documents for regulatory compliance.
• Maintain audit readiness by addressing facility and documentation issues.
• Investigate OOS, OOT, change controls, deviations, and CAPA in the block.
• Perform surprise checks for online documentation of non‑conformances.
• Prepare and review qualification, validation and other GMP documents.
• Participate in internal and external audits to assure system control.
• Review new batch manufacturing records, SOPs, and APQR for correctness and completeness.
• Ensure adequate and trained manpower across shifts for production continuity.
• Plan and deliver training on SOPs, guidelines, and safety policies.
• Monitor employee and workplace safety to maintain a safe environment.
• Ensure operations are performed in accordance with safety norms.
• Coordinate with HSE to provide PPEs and conduct safety trainings.
• Implement packaging excellence practices for continuous improvement.
• Review machine performance reports during shift performance dialogues.
• Monitor OOE data and use the PDCA system to minimize losses.
• Track monthly changes over time for machines to sustain baseline performance.
• Prepare plans for utilization of bottleneck machines to reduce time loss.
• Monitor yield of runner products to ensure it stays above baseline.

• Meeting priority demands during conflicting equipment requirements in a multiproduct facility.
• Maintaining production schedule during facility renovation and equipment upgrade.
• Utilizing capacity per the production plan amid volatile demand.
• Extending lead time for regulatory document approvals by stakeholders.
• Managing machine spare unavailability due to limited budget.
• Long cycle times for variation approval or modification in batch manufacturing records.
• Addressing quality issues in raw material (e.g., lumps, foreign material).

• Quality Assurance/Control: Scheduling of batches and product issues (Daily)
• Engineering & Utility: System‑related queries (Daily)
• Technical Support: Product troubleshooting (Case basis)
• Technology Transfer: Support for new products (Project basis)
• Stores and Warehouse: RM/PM related activities (Daily)
• EHS: Safety rounds and PPEs (Daily)
• Capacity Planning, R&D, RA: Multi‑formula harmonization and batch size optimization (Case basis)
• QA and CQA: Preparation and implementation of SOPs (Case basis)
• IT: Computerised system validation (Case basis)
• Central SCADA Team: Real‑time process data acquisition and control (Fortnightly)
• Original Equipment Manufacturers: Operation queries and machine spare queries (Monthly)
• External Auditors: Facility audits (as per schedule)
• Equipment Tooling…