Description
A biopharmaceutical organisation currently requires a QA Validation Engineer to join their team to ensure that all key validation related documents are developed, executed and reviewed in accordance with GMP regulatory and corporate and internal requirements.Main duties and responsibilities:
-Review / Approval of Validation Protocols ( e.g. URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
-Review / Approval of Validation Reports ( e.g. URS, Facility, Utility, Process, Cleaning, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU,FDA and Corporate Standards and Internal Procedures
-Resolve and assist in the closure of discrepancies initiated during Qualification execution.
-Ensures that change requests and Document Change Requests are compliant with all applicable procedures. This will involve actively reviewing the CR`s and the underlying documents for compliance and the ability to be understood by third party reviewers. Responsible for providing feedback to the originators, approvers, and site management.
-Develop/Review/Approve Validation Plans.
-Implement, deploy and revise as applicable Validation procedures.
-Conduct training in Validation Methodologies and related procedures as required.
-Provide guidance to project teams on Validation strategy and approach.
-Generate SOP`s/other documentation as applicable.
-Adherence to FDA 21 CFR Parts 600, 606, 210, 211, 820 and 11.
Education and Experience:
-Minimum of degree qualification in relevant science and/or engineering discipline
-Extensive experience with working in a regulated environment preferably within a Pharma/Biotech facility
-Experience in a Validation function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations
-Have a strong working knowledge of statistical techniques in the use of problem solving/ data analysis
-Experience of coordination of Quality documentation and in particular, qualification/Validation documentation and using an electronic document management system.
Please apply today with a covering letter highlighting your key skills and relevant experience aligned to this contract opportunity.