Quality Assurance Specialist

This role offers an opportunity to contribute within a leading global biopharmaceutical manufacturing environment, focused on the production and supply of innovative human therapeutics. The facility specializes in aseptic drug product operations, including formulation, vial/syringe filling, lyophilisation, and packaging, supported by on-site laboratories and cold-chain warehousing capabilities.The Quality Assurance Technical Support (QA TS) Specialist is a key position within the site Quality Assurance function and reports to a QA Manager. The successful candidate will act as a Subject Matter Expert (SME) within assigned areas, providing quality oversight and ensuring compliance with regulatory and corporate expectations.Key ResponsibilitiesProvide overall quality direction and oversight for key functional areas such as inspection, validation, quality control, and engineering, ensuring that all programs, policies, and procedures are compliant, effective, and aligned with regulatory requirements.Perform quality review and approval of validation documentation and SOPs, supporting site validation activities, including:Review of design specifications (DS) and quality risk assessments (QRAEs)Review and approval of validation plans, protocols (IQ/OQ/PQ), and associated documentsAssessment and approval of executed validation reportsProvide QA oversight of change controls, deviations, and CAPAs, ensuring appropriate scope definition, robust implementation, and timely closure.Participate in Change Control and Deviation Review Boards to provide quality input and decision-making support.Support a safe and compliant working environment, adhering to all environmental, health, and safety standards and procedures.Perform all activities in compliance with applicable safety, quality, and regulatory standards.Contribute to continuous improvement initiatives and process optimization projects within QA and cross-functional teams.Preferred QualificationsBachelor’s degree in a Science or Engineering discipline (advanced degree preferred).Minimum 7 years of experience in the pharmaceutical or biotechnology industry, ideally providing quality oversight across key functional areas such as packaging, inspection, validation, quality control, engineering, or information systems.Strong understanding of validation principles and new product introduction (NPI) processes.Proven experience managing change control, non-conformance, CAPA, and validation activities within a GMP environment.Ability to work effectively across cross-functional boundaries, both internally and externally.Strong critical thinking, communication, and organizational skills.Self-motivated and capable of operating independently with minimal supervision.Skilled in facilitation, coordination, and collaborative problem solving.Team-oriented professional who thrives in a collaborative, decision-driven culture.