QA Technical Specialist/ Change Management/ Regulatory

Job Overview The QA Technical specialist has a key role considering that this role is supporting the site Change Management operation. This role is responsible for review and audit of validation/ qualification /verification activities including but not limited to manufacturing, packaging, utilities, facilities, laboratories, and systems. Actively participate in the definition of validation/qualification strategies for the product being transferred from other sites and changes to site products including the Regulatory Impact Assessment (evaluation of markets requirements and contact with Regulatory principals above site). Review and approve Operational Qualification and Performance /Process Qualification and Verification and SOP associated to these processes. In addition, this role Review and approve analytical test methods validation/verification reports, specifications, tests methods, laboratory instruments qualifications, periodic review, Risk Assessments, Commissioning Documentation, Installation Certification and Master Batch Records which includes manufacturing and packaging. Responsible for the coordination of Change Requests for Qualified Production Records, Equipment, Systems, and Facilities (CR) by reviewing CR, assigning tracking number, safekeeping original CR, and closing out completed CR. Reviews proposed changes documentation, perform the assessment of the regulatory impact of proposed changes and assures completeness of required documents prior to approval. Supports the PCF sponsors in the preparation of change requests by providing needed regulatory documents. Creation and revision of Export profiles of assigned products. Support all activities of new R&D Products including change controls, development and validation documentation among others Support APR contributions process Review documentation and CC related to shipping labels and artwork Requirements: The candidate must have at least 10 years of experience in the industry and/or the activities. Available to work On site Knowledge in Manufacturing, Packaging, Laboratory, System, Facilities Bachelor Degree in Science or related Job Type: Contract Work Location: In person