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Emil Pharmaceutical
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Executive - Quality Assurance

Executive - Quality Assurance

Emil Pharmaceutical

4 - 7 years

|

5 - 8 Lacs

Boisar

Posted:1 week ago| Platform:

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Skills Required

Documentation Validation Protocol change control Risk Assessment Investigation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Review and approve validation protocols (IQ/OQ/PQ), reports, and related documentation for manufacturing equipment, utilities, and processes.
Provide QA oversight during the planning and execution of process validation and cleaning validation activities.
Ensure all validation activities are conducted in accordance with current Good Manufacturing Practices (cGMPs), company policies, and industry standards.
Participate in risk assessments (e.g., FMEA) to support validation strategy development.
Support investigations and change controls related to validated systems or processes.
Collaborate with Manufacturing, Engineering, QC, and Regulatory Affairs to ensure validation deliverables are aligned with product quality requirements.
Maintain validation documentation and ensure data integrity in all QA records.
Conduct QA review and approval of protocols and reports for re-validation and periodic reviews.
Support internal and external audits and inspections, providing SME support for validation topics.

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Emil Pharmaceutical

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