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.