9 - 12 Years
New York, USA
1. Job Purpose
- B Pharm preferred.
- 9-12 years of experience with 5-6 years of experience in formulation manufacturing at middle management level.
- Understanding of formulation manufacturing operations, safety & cGMP systems, Site transfer.
- Machine procurement and qualification related to brown field projects.
- Leading a team of 40-60 employees (depending on the unit assigned) at our Long Island.
- manufacturing facility in Hauppauge/Central Islip.
Manage, control and upgrade the manufacturing activities in the production area with optimum
utilization of resources in order to ensure smooth operations in line with safety & cGMP to
meet production targets, and produce a quality product within timelines.
2. Key Accountabilities
List the expected end results that must be achieved in order to fulfill the job purpose and the
- activities that help in achieving these results
- Accountability Cluster and Major Activities / Tasks
- Review and monitor monthly production plan for the area by considering product demand
- and available resources to facilitate smooth operations and meet production targets.
- Review the available resources, production requirements & forecasts of a block as per
- production plan and monitor its implementation.
- Liaise with QC for release of an analysis of batches/input material and with warehouse for
- RM/PM availability.
- Liaise with quality assurance to get the approved documents triggered through QMS.
Monitor the daily production operations to ensure efficient operations and delivery as per
business needs while ensuring compliance with regulatory and statutory norms.
- Review of planned production v/s actual production of the site as per production schedule.
- Maintain operational efficiency by guiding the team to resolve issues and drive
- Identify the bottlenecks in the course of production in a block and mitigate the same.
- Review documents like gap analysis, BMR, BPR, and FMECA, etc.
Monitor all activities to be in adherence to HSE standards and statutory compliance at the site
through periodic reviews to avoid accidents & create a safe working environment
- Review safety systems and procedures followed in the plant in coordination with HSE
- Evaluate and mitigate potential hazards in the department by tracking all incidents/accidents
- and implementing CAPAs.
- Ensure safety training completion in the department by coordinating with the HSE department.
Maintain the integrity of online documentation & compliance to cGMP by tracking the
systems and controls at the site to meet regulatory and customer requirements and deliver quality
- Review and approve GMP documents and maintain the integrity of documentations during
- regulatory and customer audits.
- Investigate failures/deviations, market complaints and implement CAPAs.
- Monitor the execution of appropriate validation, qualification, and calibration of equipment
- and apparatus are performed and recorded by conducting review meetings.
- Review the change controls and communicate their impact on documents and facility to
- QA/QC, engineering, etc.
- Ensure training is imparted on documentations, critical process parameters, changes being
- made & failures or deviations to adhere to cGMP requirements.
- Ensure compliance of the action plans generated in QMR w.r.t. cGMP, safety, and process
Monitor the maintenance of machines as per standards to avoid uncertainty in the operation
and adherence to the approved budget to reduce overheads.
- Review processes to close maintenance issues by coordinating with the engineering department.
- Track and optimize the utilization of manufacturing consumables.
- Track and optimize the manpower resources used for the smooth execution of departmental
- Ensure the facility upkeep and rectify issues related to facility management and
- documentation for audit readiness.
Drive continuous improvements and ensure a reduction in process cycle time through
operational studies to reduce production cost and make the capacity available without CAPEX
- Conduct operational study to find improvement areas and implement new development
- Drive continuous automation of processes through identification, review & implementation
- of new technology & software.
- Review the reject analysis and target the elimination of variables in the process resulting in yield & efficiency improvement.
- Propose and execute brownfield projects for capacity enhancement.
Monitor the implementation of the plan set for completion of site transfer to ensure on-time
- Review documents like gap analysis, BMR, BPR, and FMECA, etc. in coordination with Tech
- Transfer and monitor the production of batches.
- Execute AVD while adhering to regulatory requirements to avoid complexity during
- Provide Tech Transfer training to employees with the help of the Tech Transfer department.
Mentor and coach the teams by imparting the training at all level to avoid operating error,
adhering to GMP practices in-process failure and energy saving
Unfortunately, candidates requiring a visa will not be accepted. American Citizens or Greencard holders are required for this role. applicants only.
- Schedule and conduct the training to all shop floor staff to understand cGMP and safety
- Train the manpower for change room practices, personal hygiene, and other related SOP.
- Provide awareness training on energy saving, warning letter & other regulatory
- Provide insights to all concerned persons on any market complaint received at unit, site or other locations.