Quality Assurance Validation Specialist

Job title: Quality Assurance Validation SpecialistCompany: Advanced Therapies LLC d/b/a Minaris Advanced Therapies (Philadelphia Pennsylvania)Duties: Serve as primary resource for the review and approval of equipment/software validations (including the IQ OQ PQ and Computer Software Validation IOPQ) System Life Cycle Documentation (Validation Plans Design Specifications Requirements Specifications User Requirements etc.) Change Controls Action Items OOTs/Investigations accordance with industry guidelines (FDA EU ICH ISPE GAMP ISO etc.). Provide guidance for equipment/software related issues and consults with QA Management to resolve complex quality issues in a timely manner. Provide quality review and/or approval of validation project plans that support site priorities and validation activities associated with changes to new and existing systems. Determine the acceptability of testing results against pre-determined criteria through review of data. Perform quality review approvals of Change Requests related to introduction of equipment and changes to the qualified state of equipment. Partner with application owners and system implementation teams to ensure CFR Part 11 compliance if applicable providing consultation and support to meet project goals and objectives. Write review or approve Periodic Reviews. Champion site and regulatory standards and provide guidance through the validation life cycle to ensure adherence to current regulatory standards. Stay current with changes to GXP including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH ISPE GAMP ISO etc.). Issue review or approve document change requests SOPs IQ/OQ/PQ protocols and other applicable documentation. Requirements: Bachelors degree or foreign equivalent in Biomedical Engineering Chemical Engineering or a closely related field and 3 years of experience in the position offered or related. Must have 3 years of experience with: writing reviewing and/or approving equipment and software validations including IQ OQ PQ and CSV-IOPQs; applying knowledge of 21 CFR Part 11 and ISPE GAMP 5; applying knowledge of GLP and cGMP requirements guidelines and ISO requirements; applying knowledge of relevant GXP (Good Practice) including FDA and EU and other regulatory bodies as well as guidance documents including ICH ISPE GAMP and ISO; working with laboratory/manufacturing/facility staff to provide expertise on equipment/software validations and address conditions/practices with appropriate personnel; and writing reviewing and/or approving Change Controls and issuing reviewing and/or approving document change resume to Advanced Therapies LLC at and reference position title in subject line.