Quality Assurance Executive

1 week ago

Ahmedabad, India Maven Profcon Services Full time

**Experience**: 0 - 5 Yrs.

**Qualification**: MS-Regulatory affairs, Diploma in Regulatory Affairs, M Pharmacy, B.E Biomedical engineering, M.sc Biotechnology, M.sc Microbiology & graduation/post-graduation in any related scientific discipline

you shall:
**Quality Management System**:

- Prepare quality management system documentation as per standard requirements of ISO 9001, ISO 13485, 21 CFR Part 820, MDSAP, Integrated quality management system based on combination of aforementioned
- Gap analysis of existing QMS documentation and recommendation/working on changes
- Implementation of QMS within the clients’ premises and training employees in clients’ organization on how to adequately fill the formats and retain them
- Communicate with client on routine basis for project related information and data
- Collect, review and integrate data in documentation
- Visit to Project site for understanding manufacturer’s practices to be integrated in the technical documentation and for implementation
- Attend to client queries, doubts and review comments
- Conduct initial Internal Quality Audit and Management Review Meeting at client premises and also support client for certification audits
- Departmental activities, discussions and research for continual improvement
- Keeping up with updates in standards, guidelines and other regulatory requirements
- Where needed support in preparation of training material and conducting training for various in-house, open-house, online and customized trainings requested by clients.

**Quality Review**:

- Cross Review of technical documentation prepared by Regulatory department and preparing review report.
- Verification of work done against the review comments

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