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.

 
location: Fall River, Massachusetts
job type: Permanent
salary: $90,000 - 102,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:

• 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 realize optimum utilization of manufacturing consumables
• Close maintenance issues by reviewing processes to meet production targets by coordinating with Engineering
• Optimize the utilization 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 utilization 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 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

 
qualifications:
Education and Experience

• Bachelor's degree, or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university is preferred.
• Minimum of five to nine (5-9) years' experience in formulation manufacturing with understanding of manufacturing procedures, cGMP and systems related documentation in a cGMP pharmaceutical operation environment.

Technical Knowledge and Computer Systems Skills

• Understanding of machines used in pharmaceutical manufacturing.
• Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Must be proficient in computer skills and software applications such as Microsoft Office tools.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) is a plus.

 
skills: Good Manufacturing Practices (GMP)