QA Executive

ubio Biotechnology Systems Pvt Ltd

1 years

1 Lacs

cochin

Posted:3 hours ago| Platform: GlassDoor logo

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Skills Required

management audits compliance documentation test manufacturing dispatch engineering healthcare communication

Work Mode

On-site

Job Type

Full Time

Job Description

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.
Minimum 1 year of proven experience in the role of QA/RA, preferably in the medical device, pharmaceutical, or healthcare industry with a good communication skills.

Job Type: Full-time

Pay: From ₹12,000.00 per month

Work Location: In person

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