Job Duties Outline job duties/responsibilities below:
To ensure that engineering, qualification & validation records are developed and maintained as per the cGMP and GDP requirements & SOP.
Coordination with design consultant as required and respective user department for the design of process/manufacturing equipment (Manufacturing Vessel, Blender, Filling lines etc.).
Review & approval on detailed design as submitted by vendors (e.g. Manufacturing Vessel, Blender, Filling lines etc.).
To ensure project execution work and follow-ups with different departments (QA, QM, Operations etc.) to meet the project completion within stipulated time frame.
Effectively communicate & discuss related to day to day activity and concerns within team for efficiency and performance improvement.
To prepare, review & update of standard operating procedures at regular intervals to meet cGMP requirements.
To ensure the compliance of current Good Manufacturing Practices of related process/manufacturing equipment (Manufacturing Vessel, Blender, Filling lines etc.).
To ensure that Preventive Maintenance is developed for relevant equipment/processes in co-ordination with the relevant departments as per schedule.
Responsible for development, execution and review of Qualification / Re-Qualification and Validation activity of related process/manufacturing equipment (Manufacturing Vessel, Blender, Filling lines etc.)
To ensure the compliance of Engineering Department activities as per Quality management system.
Review & verification of Engineering department standard operating procedures at regular intervals to meet cGMP & Regulatory requirements.
To carry out FAT/SAT activities as required for newly installed equipment/Systems.
Installation and Operational qualification activity of related process/manufacturing equipment (Manufacturing Vessel, Blender, Filling lines etc.).
To ensure the calibration of relevant Engineering Department instruments are performed as per validation requirements and documented as required per cGMP requirements.
To ensure that all Engineering changes are assessed and implemented as per cGMP and local SOP.
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