-B Pharm preferred.
-10-14 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.
1. Job Purpose
Manage, control and upgrade the manufacturing activities in production area with optimum utilization of resources in order to ensure smooth operations in line with safety & cGMP to meet production targets, and produce quality product within timelines.
2. Key Accountabilities
List the expected end results that must be achieved in order to fulfil the job purpose and the activities that help in achieving these results
Accountability Cluster and Major Activities / Tasks
I. Review and monitor monthly production plan for area by considering product demand and available resources to facilitate smooth operations and meet production targets
Â· Review the available resources, production requirements & forecasts of a block as per production plan and monitor its implementation
Â· Liaise with QC for release of analysis of batches / input material and with warehouse for RM/PM availability
Â· Liaise with quality assurance to get the approved documents triggered through QMS
II. Monitor the daily production operations to ensure efficient operations and delivery as per business need while ensuring compliance to regulatory and statutory norms
Â· Review of planned production v/s actual production of the site as per production schedule
Â· Maintain operational efficiency by guiding the team to resolve issues and drive improvements
Â· Identify the bottlenecks in the course of production in a block and mitigate the same
Â· Review documents like gap analysis, BMR, BPR and FMECA etc.
III. Monitor all activities to be in adherence to HSE standards and statutory compliance at site through periodic reviews to avoid accidents & create a safe working environment
Â· Review safety systems and procedures followed in the plant in coordination with HSE department
Â· Evaluate and mitigate potential hazards in department by tracking all incidents/accidents and implementing CAPAs
Â· Ensure safety training completion in department by coordinating with HSE department
IV. Maintain the integrity of online documentation & compliance to cGMP by tracking the systems and controls at site to meet regulatory and customer requirements and deliver quality product
Â· Review and approve GMP documents and maintain integrity of documentations during regulatory and customer audits
Â· Investigate failures/deviations, market complaints and implement CAPAs
Â· Monitor the execution of appropriate validation, qualification and calibration of equipment and apparatus are performed and recorded by conducting review meetings
Â· Review the change controls and communicate their impact on documents and facility to QA/QC, engineering, etc.
Â· Ensure training is imparted on documentations, critical process parameters, changes being made & failures or deviations to adhere to cGMP requirements
Â· Ensure compliance of the action plans generated in QMR w.r.t. cGMP, safety and process improvements
V. Monitor the maintenance of machines as per standards to avoid uncertainty in operation and adherence to approved budget to reduce overheads
Â· Review processes to close maintenance issues by coordinating with engineering department
Â· Track and optimise the utilisation of manufacturing consumables
Â· Track and optimise the manpower resources used for smooth execution of departmental activities
Â· Ensure the facility upkeep and rectify issues related to facility management and documentation for audit readiness
VI. Drive continuous improvements and ensure reduction in process cycle time through operational studies to reduce production cost and make the capacity available without CAPEX
Â· Conduct operational study to find improvement areas and implement new development projects
Â· Drive continuous automation of processes through identification, review & implementation of new technology & software.
Â· Review the reject analysis and target the elimination of variables in the process resulting in yield & efficiency improvement.
Â· Propose and execute brown field projects for capacity enhancement
VII. Monitor the implementation of plan set for completion of site transfer to ensure on-time launch
Â· Review documents like gap analysis, BMR, BPR and FMECA etc. in coordination with Tech Transfer and monitor production of batches
Â· Execute AVD while adhering to regulatory requirements to avoid complexity during commercialization
Â· Provide Tech Transfer training to employees with the help of Tech Transfer department
VIII. 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
Â· Schedule and conduct the training to all shop floor staff to understand cGMP and safety requirements
Â· Train the manpower for change room practices, personal hygiene and other related SOP
Â· Provide the awareness training on energy saving, warning letter & other regulatory information
Â· Provide insights to all concerned persons on any market complaint received at unit, site or other locations