Senior QC Specialist (Method Validation & Technical Support)

• Lead analytical method qualification, validation, verification, transfer, and lifecycle management for chemical and biological testing
• Manage qualification of laboratory equipment, analytical instruments, and critical reagents, ensuring compliance throughout their lifecycle
• Support introduction of new methods, technologies, materials, and equipment into QC operations
• Coordinate and maintain QC stability programs, including data review and trend analysis
• Lead investigations of deviations, non-conformances, invalid results, atypical results, and OOS events
• perform root cause analysis and drive CAPA implementation
• Monitor and implement regulatory and compendial updates to ensure ongoing compliance with GMP, FDA, USP, EP, and ICH requirements
• Author, review, and approve GMP documentation including SOPs, protocols, reports, change controls, deviations, and CAPAs
• Act as a technical SME, providing guidance, training, and knowledge transfer to QC testing teams
• Support internal audits, regulatory inspections, and customer audits as the SME for assigned areas
• Drive continuous improvement initiatives to enhance analytical methods, laboratory processes, compliance, and operational efficiency
• Collaborate with cross-functional teams including QC, QA, Manufacturing, Validation, Regulatory Affairs, and Global Technical functions

• Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline
• Minimum 5 years of experience in pharmaceutical or biopharmaceutical Quality Control, Analytical Development, or Technical Support functions within a GMP-regulated environment
• Hands-on experience in analytical method validation, qualification, verification, transfer, equipment qualification (IQ/OQ/PQ), stability programs, and laboratory investigations (OOS/OOT, deviations, CAPAs, and change controls)
• Strong knowledge of GMP requirements, analytical method lifecycle management, root cause analysis, GMP documentation, and global regulatory standards including FDA, USP, EP, ICH, PIC/S, and Data Integrity principles

Exposure to biologics, vaccines, sterile manufacturing, cell & gene therapy, LIMS, CDS, electronic quality systems, or laboratory digitalization initiatives is an advantage