Senior Executive-QA
Core
Ensuring quality compliance and validation of equipment, facilities, and processes in a pharmaceutical CDMO environment.
Role type
Senior Quality Assurance Executive (Validation & Compliance)
Domain
Pharmaceutical manufacturing / Contract Development and Manufacturing Organization (CDMO)
Required skills
Protocol preparation and execution, Risk assessment (ICH Q9), Change control impact assessment, Vendor management, Audit coordination, Data Integrity monitoring, CAPA investigation, Document control, Training delivery
Preferred skills
Experience with temperature mapping, Media fill and SIP Validation, IT Supplier Assessment, EHS compliance
Technologies
Track Wise, ENSUR, VMP, ICH Q9
Responsibilities
Prepare and review protocols for equipment, area, HVAC, and utility qualification; Perform media fill and SIP validation; Conduct risk assessments and change control impact assessments; Coordinate with cross-functional teams and vendors for validation activities; Handle audits (internal/external) and corrective actions; Manage QMS activities including deviations and CAPA; Support Data Integrity Compliance Officer; Ensure EHS activity completion.
