Qa Specialist Mat. Leave

The Quality Assurance specialist will entail ensuring compliance with all regulatory and corporate requirements in support of regulatory, internal standard and customer expectations, by carrying out routine quality assurance and quality control tasks and activities.The Quality Assurance specialist will handle Deviations, CAPA, Product Alert, to ensure the systems compliance with all Domestic, Global regulatory and corporate requirements.The Quality Assurance specialist will conduct QA Oversignt (and audits to laboratories, development, warehouse and all Site Departments) to assure compliance to current standards/ISO and collaborate to resolve quality concerns, by fostering the implementation of quality improvements and by meeting with Managers, Supervisor to assure current methods, procedures or SOP's meet current standards. Main responsibilities are: check department daily or weekly to control for the whole process; prepare the SOPs for quality management (Deviation, CAPA, Product Alert,etc..); review and approve the SOPs from other departments; review the validation and qualification document and Investigation of quality issue; deviation management; ensure to fulfill the KPIs of QA; actively participate in quality culture building and quality related activities; actively report quality related events and participate in continuous quality improvement activities; manage all quality audit aspects of Suppliers, Packagers, Distributors, Warehouses, Contract Laboratories as appropriate. Who you are: Minimum bachelor's degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, or a related disciplineAt least 3 years of working experience in a pharmaceutical or biological GMP/ISO environment with GMP/ISO experienceNew project experience and build-up of quality management system are preferredFamiliar with GMP regulations/guides and quality management processFluent in EnglishResult orientation, accuracy and reliability as a mustExcellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability