12 Aug
|
POST A RESUME
|
Ahmedabad
12 Aug
POST A RESUME
Ahmedabad
Job Description:
Minimum 20 years in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with significant exposure to regulated markets
To provide strategic and operational leadership to the Quality function, ensuring robust implementation of quality systems, compliance with global regulatory requirements, and continuous improvement in all quality-related processes for API manufacturing.
Key Responsibilities
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Quality Systems & Compliance
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Implement, maintain, and continuously improve Quality Systems in line with ICH Q7, EU GMP, 21 CFR Parts 11, 210, 211, Annex 11, and other applicable global regulations for APIs.
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Ensure site-wide compliance with internal quality policies, SOPs, and regulatory guidelines.
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Oversee preparation, revision, and effective implementation of quality-related SOPs, policies, and quality manuals.
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Vendor Qualification & Management
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Establish and maintain procedures for vendor approval, qualification, periodic evaluation, and rejection.
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Ensure technical and quality assessment of raw material, intermediate, and service providers in alignment with regulatory and company standards.
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Drive supplier quality improvement initiatives and manage critical vendor-related quality issues.
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Change Control, Deviations, Risk & Product Quality Review
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Review and approve major process changes and critical quality-impacting changes through the Change Control system.
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Review and approve Annual Product Quality Reviews (APQR/PQR) and ensure implementation of improvement actions.
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Review and approve critical deviations, investigations, and associated Corr
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