Preparation of SOP / schedule for Equipment/ Facility as per GMP documentation of API plant.
Preparation engineering deliverables including Specifications, Datasheets, PM schedules etc.
Responsible for GxP documentation i.e. Change initiation, DQ, SAT, IQ, OQ.
Understanding and ensuring quality compliance with cGMP, GDP, GEP,GAMP, 21 CFR part 11
Good in computer skills and preparation of daily/monthly excel reports, work power point presentation and using of industrial software i.e. Priority.
Handling complete mainatence module for preventive/ breakdown/productive maintenance of equipment’s.
To use the problem-solving tools to find out the root cause of any failure and implement the CAPA accordingly.
Expertise in problem Solving tools to find out the root cause of any failure and implement the CAPA. FMEA, Root cause analysis, with in depth knowledge about the latest Maintenance techniques and CI tools-5S, Kaizen, 5 why Analysis, RCA, CAPA.
Preparation of investigation report and CAPAs.
Tracking and implementation of GxP and EHS CAPA.
Tracking and maintaining of down time of site related to engineering.
Maintaining all documentation for engineering department.
Maintaining statuary & regulatory compliance for department.
Responsible for spare part management for engineering department.
Preparations of budget requirement for engineering department.
Tracking of departmental budget to maintain the allocated budget.
Responsible to carry out the preventive maintenance of cGMP equipment, critical equipment and its subparts etc. as per schedule.