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.
- 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)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
