This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards and oversees a team of Validation Specialists. As an Associate Manager in QA Validation, duties will include
- This position implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards and oversees a team of Validation Specialists. As a Associate Manager in QA Validation, a typical day may include
- Manage, develop, and build a team of subject matter experts in the areas of cleaning validation and SIP validation and continuing validation.
- Day to day management of resources, planning and assigning work to Validations Specialists and/or contingent workers to meet goals and deadlines. Ability.
- Lead multiple and sophisticated validation programs, provide status reports and coordinating with other departments or outside contractors/vendors to complete validation tasks.
- Lead technical and quality investigations. Collaborates with functional departments to resolve issues.
- Manage a cross-functional project with many stakeholders Review, edits and approves change controls, SOPs, reports, and other documentation Reviews.
- Approve master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria Review,
- Edits and approves deviation notifications, deviation investigations, and corrective actions. Trains/advises less experienced Specialists.
- May present at both internal and external (regulatory) audits if required. Stays current with industry trends, regulatory requirement updates, and presenting same to team Performs other duties assigned by Management. Some travel may be required. Education and
- BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of related experience within the field preferred, may substitute relevant experience for education.
- Previous team/people management experience essential. Previous cleaning validation and steam in place experience an advantage.
- Understanding of Biopharmaceutical Drug Substance manufacturing process an advantage.