27 Aug
|
ACG
|
Mumbai Suburban
27 Aug
ACG
Mumbai Suburban
Role & responsibilities
1. Perform Machine Installation Test Report (ITR) activities, including:
- Machine interlock verification.
- Verification of 21 CFR Part 11 compliance features.
- SCADA and HMI screen verification.
- Functional testing of machine operations as per approved protocols.
2. Execute and complete the Machine Factory Inspection Test Protocol (MFITP) by performing the required verification activities and accurately documenting all observations and test results.
3. Capture and maintain screenshots of SCADA/HMI screens and generate report printouts/PDFs for future reference, documentation, traceability, and audit purposes.
4. Perform detailed verification of machine hardware components and complete the Hardware Design Test Protocol (HDTP) by documenting inspection results and ensuring compliance with design and quality requirements.
5. Support the Quality Assurance (QA) team during ITR, IFAT (Internal Factory Acceptance Test), and CFAT (Customer Factory Acceptance Test) activities by assisting in testing, verification, documentation, and timely closure of observations.
6. Ensure all testing and documentation activities are performed in accordance with approved SOPs, validation requirements, GMP guidelines, and applicable quality standards.
7. Maintain accurate and complete test records, report deviations or non-conformities identified during testing, and coordinate with cross-functional teams for timely resolution.
Immediate joiners preferred.
📌 Apprenticeship Trainee- ACGE PAM Kandivali (Mumbai Suburban)
🏢 ACG
📍 Mumbai Suburban