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Validation Specialist Contract
2 weeks ago
Job Overview
">We are seeking a highly skilled Validation Specialist to join our team on a 12-month contract basis. This is an exciting opportunity to work with a global pharmaceutical company and be part of a diverse and experienced team.
">Key Responsibilities
">The successful candidate will ensure all computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements. This will involve coordinating, directing, and actively participating in the validation of site equipment, facilities, utilities, processes, and software in compliance with company policies, FDA, European cGMP, and GAMP standards.
">Additional Responsibilities
">Generate and maintain Validation Master Plans and Project Validation Plans. Create validation plans, protocols, and final reports adhering to cGMP standards. Review and approve all protocols and final reports. Manage the validation change control process. Adhere to and support all EHS & E standards, procedures, and policies.
">Requirements
">To be considered for this role, applicants must have a strong background in engineering or science. A minimum of 5-10 years' experience in a cGMP regulated environment is required. Good understanding of regulatory requirements is essential.
">Preferred Qualifications
">Experience in Process validation (PPQ) in API or drug product, and managing validation events / Non-Conformances during PPQ. FUE qualification is essential (preferably API). Experience with fast-paced projects is also desirable.
">Why You'll Thrive Here
">This role offers the opportunity to work on exciting projects and develop your skills in a dynamic environment.
