Title:  Manager - Engineering - QMS

To participate in the investigation, root causes identification and derive CAPA in case of incident of system failures/out of specification observation and request change control, action item through Track wise.

Handling all QMS activities related to UPD/PD/CAPA/CC/Audit observations.

Ensure completion of all QMS activities related to UPD/PD/CAPA/CC/Audit Observations.

Inter-departmental co-ordination for engineering related QMS activities.

To follow GDP, GMP GEP Procedures.

Documentation work related to audit requirement.

Initiate & review change control, action item through trackwise.

Preparation and review of SOP in EDMS system.

Document management through EDMS.

Handling of LMS for training and act as department training co-ordinator.

Evaluation of change controls in engineering department.

Assisting in renovation work and project work.

To follow safety and EHS guideline in project as well as routine work.

To assist in performing HVAC qualification & validation activities.

Preparation and review of validation qualification protocols.

Periodic review of engineering related document and ensure compliance to procedures.

To ensure that all training related activities are carried out as per schedule and procedure. To complete & update all training related documents in one month time period. (training calendar, training matrix, training files)

To handle the observations & ensure timely compliances of the observations/points same within timeline.