QA/ra Executive

2 weeks ago

Kochi Kerala, India ubio Biotechnology Systems Pvt Ltd Full time

**Key Responsibilities**:

- Maintain and continually improve the Quality Management System (QMS) in accordance with ISO 13485 and applicable international and local regulatory requirements.
- Conduct and oversee internal quality audits, assess compliance, and identify areas for improvement.
- Manage non-conformances, and implement corrective and preventive actions (CAPAs) to ensure timely and effective resolution.
- Coordinate and prepare for external audits, including inspections by regulatory authorities and other customer audits.
- Review and approve quality-related documentation, including Standard Operating Procedures (SOPs), work instructions, and quality records.
- Prepare, compile, and review regulatory dossiers in accordance with country-specific guidelines and CTD (Common Technical Document) format.
- Handle submissions through applicable regulatory portals for product registrations, Test Licenses, Manufacturing Licenses, and other required authorizations.
- Review all regulatory documents for accuracy, completeness, and compliance with applicable guidelines.
- Ensure timely dispatch of tender and regulatory documents to relevant authorities or partners to meet submission deadlines.

**Qualifications**:

- Bachelor’s or Masters degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field.
- Proven experience in the role of QA/RA, preferably in the medical device, pharmaceutical, or healthcare industry with a good communication skills.

Pay: From ₹12,000.00 per month

Schedule:

- Day shift
- Morning shift

Work Location: In person

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