Job Description

To understand the technical requirements related to calibration or validation or qualification To assist in preparation the project and quality plan for all the projects at hand. To prepare the document list based on the project scope, project, and quality plan. To inform all the other departments / site team / validation team / Calibration team about the project documentation and quality requirements. To collect or prepare, check, comment, modify, and approve the documents as per the list for all the areas of procurement, installation, commissioning, qualification, validation, and handover. To track all the documents in the project scope list for availability, correctness, and approvals from the project team, concerned departments, and clients. To assist in preparation of critical qualification and validation documents in house, like but not limited to user requirement specifications (URS), validation master plan (VMP), project and quality plan, impact analysis, corrective action and preventive action (CAPA), standard operating procedures (SOPs), lists, risk management, risk analysis, etc. To assist in preparation and update standard templates for working like URS, design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), handover forms, installation protocols, commissioning protocols, etc. To maintain the document history and trail for all documents in the project. To verify the documents and drawings to meet the standards of submission as defined in the project and quality plan, like numbering, formats, signature panels, approvals, etc. To confirm with the client, verify all approvals, document receipts, and maintain records of the same. To study and understand the project quality and documentation requirements from the project brief with the help of the project design team/ Sales team / Customer. To follow up on all site activities documentation, which includes installation, commissioning, qualification, validation, and handover. If needed, visit the site as per requirement. To be responsible for tracking and sending protocols to the site as per testing and reporting requirements. To report to the customer on the ongoing work and any contingencies and requirements that arise during testing. To collect the raw data from the site engineer after testing work. To prepare internal or external reports of validation or calibration or qualification after receiving customer's approval on the format or the template. To send and get approved all the draft validation or calibration or qualification reports from the customer. To finalize the final approved report with customer and send originals or scan copies to the customer for report handover and completion certificate. To maintain equipment logs and calibration certificates in database.

Skills and Knowledge:

Basic knowledge of heating, ventilation, and air conditioning (HVAC), clean room construction, clean room flooring, piping, utilities, production equipment, and electricals. Some knowledge of the pharmaceutical industry in general, dosage forms in the formulation industry, various equipment's and systems that go into the operation and construction of a facility. Fluent in both written and spoken English and Hindi. Self-starter and motivated to achieve goals and targets. Should be able to draft templates and documents as per standard requirements.
Job Types: Full-time, Permanent

Pay: ₹15,000.00 - ₹21,000.00 per month

Benefits:

Health insurance Paid sick time Paid time off Provident Fund
Schedule:

Monday to Friday
Experience:

Quality assurance: 2 years (Preferred) Documentation: 2 years (Preferred) Validation: 2 years (Preferred) Calibration: 2 years (Preferred)
Work Location: In person