Engineering- Offer/ Executive

Role & responsibilities

The candidate shall possess the following knowledge and practical competencies:

1. Change Control and Incident Management: Knowledge and practical experience in initiating Change Controls and Incidents in TrackWise, conducting investigations, identifying root causes, and implementing CAPA, as applicable.
2. Documentation Management: Practical experience in preparing, reviewing, and revising SOPs, formats, checklists, and other GMP-related engineering documents.
3. Qualification Activities: Practical experience in preparing, reviewing, and executing qualification documents for utility systems and equipment, including protocol execution, data recording, deviation handling, and report preparation.
4. Computerized System Validation (CSV): Knowledge and practical experience in CSV documentation, risk assessment, test execution, and preparation of validation reports, as applicable.
5. Calibration Management: Practical experience in coordinating and executing instrument calibration, reviewing calibration certificates, monitoring calibration schedules, and handling out-of-calibration events.
6. Trend Analysis and Reporting: Practical experience in compiling, analyzing, and preparing trend reports for preventive maintenance, calibration, equipment breakdowns, utilities, and facilities.
7. Vendor and Agency Management: Ability to coordinate, supervise, and verify the work performed by external agencies and service providers in accordance with approved procedures and safety requirements.

Preferred candidate profile