Job DescriptionPrimary Function of Position:
Oversee and plan daily activities for the Product Release team and coordinate workload to ensure appropriate manpower is assigned to required activities.
Verify that Product Release tasks are well defined, and ensure the Product Release team is productive and processes are compliant with ISI Operating procedures and instructions. Ensure training is appropriate and timely for the Product Release team. Review and approve timecard submissions and related requests.
Verify manpower planning is aligned to internal customer demand, current and projected. Review individual contributors' performance and mentor as appropriate to continuously improve Product Release performance.
Roles & Responsibilities: Supervises Product Release personnel at assigned plant(s).Performs individual contributor performance reviews, timecard management, and mentoring for assigned plant.Establishes and manages Monthly/Weekly assignment of DHR, optimizing actions based on demand and manpower.Manages daily Product Release operations to ensure compliance with regulatory requirements including GDP & GMP.Reviews NCR and DN trends, taking action where necessary to drive down average duration and recurring incidents.Supports Quality audits to manage accurate data required before, during, and after audit events.Manages sterilization lots release according to data provided by sterilization suppliers and escalates adverse specification data or extended delivery dates.Keeps KPI of Product Release updated according to the frequency required by Quality Management.Supports multiple sites on SOP, DOP, WI documents update, and upgrade related to Product Release.Fluent in English speaking and writing (80% or above).May also support or assist the following Lead Activities:Verifies Product Release operations performance in accordance with procedures and instructions.Conducts training of Product Release personnel on DHR Review, SAP, Agile, Sterile product management, Bracketing, and other Quality transactions.Performs periodic audits to verify correct and consistent operations and timely execution of tasks.Ensures Product Release budget department is controlled and, if required, provides over-expend justification or continuous improvement for budget reduction.Generates and maintains DHR reports for monthly quality review meetings.Manages NCRB areas to control non-accepted products that have been wrongly used.Provides guidance and training to the Product Release team when required.Performs any other projects or duties that may be assigned.Supports lot release of multiple ISI sites.
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