Purpose:
We are partnered with our growing pharmaceutical packing client, that is looking to expand their leadership team. This role is focused on the oversight and safety of their manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and production targets in time.
Major Challenges
- Meeting priority demands during clashing equipment requirement in multiproduct facility. Overcome by efficient planning
- Keeping up with production schedule during facility renovation and equipment upgrade
- Utilization of capacity as per the production plan due to volatile demand. Overcome by rescheduling of plans
- More lead time for approval of regulatory documents by internal and external stakeholder Overcome by regular follow ups
- Unavailability of machine spares items because of limited budget. Overcome by maintaining the centralised control system for minimum stock of spare to be maintain all the time at stores for all identified machines.
- Long cycle time for variation approval or modification in batch manufacturing record due to delayed response by internal stake holder i.e. RA, R&D, LCM team and CQA, which can be overcome by defining the timelines for each stakeholder
- Issues in Quality of Raw Material i.e. lumps formation, presence of foreign material etc. Overcome by taking investigation and CAPA from the supplier
- 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 panning, R&D, RA other manufacturing unit for Multiple formula harmonization and batch size optimization (Case basis).
- QA and CQA for preparation and implementation of SOP'S (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 any operation related queries and for machine spare related queries (Monthly).
- External Auditors during facility audits (as per schedule)
- Equipment tooling suppliers for any tool related queries and updating the performance of the tools (Case Basis).
- Maintenance contractor for Instrument calibration scheduling and its execution (Monthly).
- Civil contractor for civil work (Case Basis)
location: Fall River, Massachusetts
job type: Permanent
salary: $90,000 - 100,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
Key Accountabilities
- Monitor and control planned production by daily activity review as per production plan to meet production 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 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 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 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 manufacturing excellence practises 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), Corrective and Preventive Actions (CAPA)
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.
