Senior Executive - CQA Shalina Healthcare

5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As a Quality Assurance Specialist, you will be responsible for ensuring GMP and GLP compliance through various audit activities at Loan Licence Units (LLU), Third Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs). Your key responsibilities will include: - Preparation and adherence to annual planner for Quality audits to monitor overall performance and compliance. - Reviewing audit compliance reports for external/regulatory/customer audits and ensuring timely closure of observations. - Conducting self-inspections, compiling reports, and tracking compliance for timely closure. - Coordinating technical document evaluation from vendors, arranging sample an...

Posted 14 hours ago

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Senior Executive - CQA Shalina Healthcare

5.0 - 9.0 years

0 Lacs

maharashtra

On-site

You will be responsible for preparing and adhering to the annual planner for Quality audits for Loan Licence Units (LLU), Third-Party Manufacturing Sites, public testing laboratories, and Shalina Operating Units (OUs) to ensure GMP and GLP compliance. This includes conducting periodic, due diligence, and for-cause quality audits to monitor overall performance. You will review audit compliance reports for any external, regulatory, or customer audits, ensuring the closure of individual observations by reviewing relevant supporting data. Additionally, you will conduct self-inspections of individual departments, compile reports, track and review compliance for timely closure, and maintain audit ...

Posted 2 months ago

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Quality & Compliance Specialist Amaris Consulting

5.0 - 9.0 years

0 Lacs

pune, maharashtra

On-site

The main responsibility of this role is to ensure that all project deliverables meet internal Quality Management System (QMS) standards, defined templates, and Critical to Safety (CTS)/Critical to Quality (CTQ) quality gates before submission. This involves reviewing Design History File (DHF) documents for completeness, consistency, and QMS compliance, as well as performing CTS and CTQ checks across documentation. Additionally, supporting traceability between user needs, product requirements, and verification/validation is essential. Another key aspect of the role is monitoring changes to QMS procedures/templates and managing any resulting documentation updates. Collaboration with Regulatory...

Posted 3 months ago

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