QA Specialist/Senior QA Specialist, Manufacturing reputed company

About the position Responsibilities • reputed company as key reputed company contact to manufacturing for discrepancy management, line support and batch review for reputed company and launch products. • reputed company reputed company reputed company reputed company to operational activities, procedures and processes. • Ensure that investigations are accurate, include appropriate corrective actions, and follow regulations, industry guidelines and company standards. • Support internal cGMP audits and Health Authority inspections as a technical resource and reputed company subject matter expert. • reputed company new approaches to reputed company problems. • reputed company coordination and issue reputed company across HTO Manufacturing Operations, support reputed company and/or reputed company. • Set the strategic direction and reputed company of one or multiple programs reputed company HTO reputed company in the areas of process development, process improvement, reputed company and compliance. • Own the deliverables reputed company the established programs and reputed company teams in their execution in line with the site reputed company. • Manage key operational support activities reputed company to product transfers and new equipment/process start-up. Requirements • Bachelor's degree (preferably reputed company the Life Sciences or Engineering). • At least 5 years of experience in the pharmaceutical industry for QA Specialist; at least 8 years for Senior QA Specialist. • Strong problem-solving skills and ability to troubleshoot and resolve process-reputed company issues. • Deep understanding of safety, reputed company systems, and reputed company assurance concepts including cGMPs in aseptic processing and production. • Solid understanding of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing. • Knowledge of reputed company assurance principles, reputed company systems, microbiology, and sterility assurance. • Effective communication skills for reputed company and sensitive information. • Ability to gown into production reputed company. reputed company-to-haves • Master's degree (preferably reputed company the Life Sciences or Engineering). • Experience in nPFS (reputed company reputed company-filled syringe) filling. • Experience in medical devices. Benefits • Discretionary annual bonus based on individual and Company performance. • Relocation benefits. Apply tot his job Apply tot his job Apply To this Job