Senior Executive/Assistant Manager - US QA

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Job Description

Provide remote quality assurance support to US-based manufacturing and quality operations.
Ensure compliance with global cGMP, ICH, and regulatory guidelines in all QA-related operation
Review and approve batch manufacturing records (BMRs) and certificates of analysis (CoAs).
Support deviation investigations, CAPAs, and change control activities; ensure timely closure and compliance with internal SOPs.
Provide QA guidance for tech transfers, validation activities, and process improvements.
Contribute to global harmonization of quality systems and SOPs.
Monitor and track key quality metrics; prepare periodic quality reports for US leadership.
Collaborate with cross-functional teams in Manufacturing, QC, Regulatory Affairs, and R&D to maintain consistent quality standards.
Review and approve SOPs, protocols (validation, qualification), and technical documents as per quality systems
Participate in risk assessments, root cause analysis, and continuous improvement initiatives.
Maintain electronic and paper-based documentation in accordance with ALCOA+ principles.