Validation Specialist 12개월 계약직 2년 이상 유관 경력자 제약 바이오

Job description

Your role: The Validation specialist role will perform site qualification& validation and ensure that qualification& validation activities consistently comply with all regulatory and corporate requirements in support of regulatory requirements and customer expectations. This position will also entail validation Management system operation and maintenance, to ensure the system compliance with all Domestic and Global regulatory and corporate requirements. Ensure validation employees are hired, trained, and qualified to support project execution and conduct daily operational activities. Develop site validation management procedures for equipment qualification, computerized system validation, process validation, cleaning validation, transportation verification, and HVAC/Clean Utilities ensure that site validation management procedure complies with regulatory requirements and global standards. Prepare Validation Master Plan, Validation Plans for Equipment qualification, process and cleaning validation, and Computerized Systems (PCS, MES, EMS, WMS, ASRS, LIMS) in place on schedule in collaboration with Subject Matter Experts. Conduct site qualification& validation, ensure that processes, procedures, equipment, facility, systems and methods are validated, and ensure that qualification& validation activities consistently comply with GxP/ISO regulatory requirements, corporate standards and customer expectations. Collaborate process owner/relevant dept for validation activities such as URS, risk assessment, FAT/SAT document review, validation protocol/report preparation, and execute DQ/IQ/OQ/PQ including test execution witness and result review. Carry out periodic validation status review and perform site requalification and revalidation. Who you are: Minimum bachelor’s degree in pharmaceutical sciences, life sciences, biology, biotechnology chemistry, or a related discipline. + 2 years in the pharmaceutical, biotechnology in quality assurance, GMP compliance, operations or validation, ideally in a multinational company. Experience in handling sterile product required. Experience in developing CCS and APS/APV preferred. Good communication in English. Good decision-making and problem-solving capability *내부 전보 확정 시 법인 이동이 필요한 경우, 퇴직급여 정산 또는 이전 절차 및 각종 사내대출 상환 절차가 필요할 수 있습니다. 내부 지원 시 해당 사항을 숙지하고 지원한 것으로 간주합니다.