Quality Assurance Validation Specialist

Minaris • Philadelphia, PA

23h

About The Position

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 etc., in 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

• Bachelor’s 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 requests.

What This Job Offers

• Job Type: Full-time