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

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

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 packaging targets in time.

Major Activities / Tasks

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 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

Key Interactions

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 other manufacturing unit for Multiple formula harmonization and batch size optimization (Case basis)
QA and CQA for preparation and implementation of SOPs (Case Basis)
IT for computerised system validation (Case Basis)
Central SCADA Team for Real time process data-Acquisition and control (RTPD-AC) project way forward. (Fortnightly)
Original equipment manufacturers for operation and spare part queries (Monthly)
External Auditors during facility audits (as per schedule)
Equipment tooling suppliers for tool related queries and updating performance of tools (Case Basis)
Maintenance contractor for Instrument calibration scheduling and its execution (Monthly)
Civil contractor for civil work (Case Basis)

Key Decisions

Decisions and Recommendations

Scheduling of packaging batch
Utilisation of packaging consumables
In-process checks
Manpower scheduling shift wise as per production plan and authorization of the leaves accordingly
Packaging Plan forecast…