Quality Assurance Executive
3 weeks ago
To assist the QA Management, to maintain an effective Quality Management System (QMS). Ensure compliance with ICH guidelines and regulatory requirements and provide support to the HomeNurse4U (HN4U) functions with regards to Quality Assurance (QA).
- Assists in maintaining QMS
- Supports in hosting sponsor audits and regulatory inspections
- Tracks and assists in conducting audits per the audit schedule
- Maintains accurate and timely documentation of QA related activities
- Supports in promoting quality awareness throughout HN4U
- Communicate changes and updates in regulations and guidelines to relevant HN4U staff, as needed
- Provide administrative support to all QA related work, e.g. formatting Standard Operating Procedures (SOPs) and Work Instructions (WIs); supports in creating forms and templates
- Provide day-to-day QA support to the other functions, as needed
- Tracks and manages the controlled documentation requests
- Review training records/files of HN4U staff at regular intervals.
- Ensure that all non-study specific training is filed appropriately.
- Performs other work-related activities, as assigned.
Ability to commute/relocate:
- Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (required)
**Education**:
- Master's (required)
**Experience**:
- QA: 2 years (required)
**Language**:
- English (required)
**Speak with the employer**
+91 +918758903112
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