Within this role you will be responsible for providing technical leadership and mentorship for qualification activities and data integrity initiatives in regard to small manufacturing and laboratory equipment (e.g.
HPLC/UPLC, TOC analyser, FTIR, microscopes) in the frame of Industrial Operations and Product Supply of biological products in accordance with cGxP, regulatory requirements and industry trends.
As a Principal QA Validation Specialist a typical day might include, but is not limited to, the following: Having strong knowledge and understanding of the equipment used for QC analysis and operations Supervising the end-to-end qualification process ensuring each piece of equipment fits for the intended use that contribute to 365 inspection readiness program Following, fostering and implementing a quality culture and other company manufacturing standards, policies and procedures Experiencing a strong background and are familiar with site change control, risk management and data integrity initiatives/programs Previous experience as a SME in a highly regulated environment (e.g.
pharma, biotech, medical devices) in both internal and external regulatory audits Scheduling, executing, reviewing and approving qualification activities Assessing executed change controls and deviations for impact to the qualified state for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements Reviewing, editing, and approving deviation notifications, deviation investigations and corrective actions Reviewing, editing, and approving change controls, SOPs, reports and other documentation Coordinating with other departments and outside contractors/vendors to complete validation tasks Collaborating with functional departments to resolve issues Managing and driving projects Preparing, reviewing and approving status reports Supervising, providing direction and assigning work to less experienced full-time employees (e.g.
validation specialists) and/or contingent workers to meet goals and deadlines Staying current with industry trends, regulatory requirement updates and communicating the same to a team Performing other duties that would be assigned by management Travelling may be required This role might be for you if: You have expert knowledge of EU annex 11 and FDA 21 CFR Part 11 You have strong knowledge of Data Integrity You have the ability to prioritize and handle multiple tasks simultaneously You have project management experience To be considered for this opportunity you should have BS/BA in Engineering, Chemistry or Life Sciences with 8+ years of related experience within the field preferred; may substitute relevant experience for education.
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