QA Manager

Curo Bioscience Pvt.Ltd. Hingna, Maharashtra, Hingna, Maharashtra, IN (On-site) 1 week ago

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Full Time/Permanent

Mid-Senior level

Roles & Responsibilities

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 strong organizational abilities.

Proven experience in quality management within the Life Sciences sector or related field. ISO13485 experience is absolute

Pay: ₹400,000.00 - ₹500,000.00 per year

Work Location: In person