- QMS Documentation (ISO 13485): Prepare, review, and control SOPs, formats, DHR, protocols, and records ensuring compliance with ISO 13485.
- Batch Record Review: Review BMR/DHR for completeness, traceability, and compliance prior to product release.
- Deviation & CAPA Management: Initiate, investigate, and close deviations and implement CAPA as per ISO 13485.
- Line Clearance & Shopfloor QA: Perform line clearance and ensure adherence to cleanroom and medical device manufacturing practices.
- Audit & Compliance Support: Support internal, external, and regulatory audits and ensure timely closure of observations.
- Regulatory Compliance: Ensure compliance with CDSCO, ISO 13485, and GMP requirements and assist in regulatory documentation.
Qualification & Experience
A degree in Biological or related life science degree (or equivalent)
4-6 years’ experience in quality management
Knowledge of document control and QMS software
Effective communication skills for collaborating with diverse teams.
Detail-oriented with robust organizational abilities.
Proven experience in quality management within the Life Sciences sector or related field. ISO13485 experience is absolute
Pay: ₹500,000.00 - ₹600,000.00 per year
Work Location: In person
📌 QA Manager (India)
🏢 CURO Biosciences
📍 India
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