Corporate Quality Assurance

2 weeks ago


mumbai, India RESONACLE Full time

We are seeking a highly experienced Quality Assurance leader to drive Corporate QA initiatives across multiple formulation manufacturing sites. The incumbent will be responsible for strengthening the company’s Audit, Compliance, and Validation/Qualification (VQ) framework, ensuring adherence to global regulatory standards, and maintaining continuous inspection readiness.This is a strategic corporate role requiring close coordination with site QA, manufacturing, and regulatory teams to uphold a consistent culture of quality excellence and compliance across all units.Key Responsibilities:Lead and manage internal and external audits across formulation sites (OSD, Injectables, Topicals).Ensure full compliance with USFDA, MHRA, EU, ANVISA, TGA, and WHO regulatory requirements.Oversee audit preparedness, inspection readiness, and CAPA effectiveness.Develop and implement corporate QA policies, SOPs, and governance frameworks.Review and monitor site-level quality metrics and compliance dashboards.Collaborate with site QA teams to standardize systems and close quality gaps.Review and approve validation protocols, change controls, deviations, and risk assessments.Ensure alignment of VQ activities with GMP, ICH, and data integrity requirements.Design and deliver training programs on compliance, audit management, and regulatory awareness.Act as a corporate liaison during regulatory inspections and manage post-inspection communications.Key Requirements:Education: B.Pharm / M.Pharm / M.Sc. (Life Sciences) or equivalent.Experience: 15+ years in Corporate QA within the pharmaceutical formulations industry.Proven exposure to global regulatory audits (USFDA, EU, MHRA, ANVISA, TGA).Strong understanding of GMP, ICH, QMS, and data integrity principles.Hands-on experience with CAPA systems, documentation review, and validation oversight.Excellent leadership, communication, and stakeholder management skills.Ability to travel to multiple manufacturing sites as required.



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