Validation Expert
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Our client, a leading life sciences organization, is seeking an expert to oversee validation activities for transport and CMO-manufactured products. This role ensures the compliance of validation lifecycles, protocols, and risk assessments while serving as a key technical point of contact for regulatory submissions and audits.
- Develop, review, and approve transport validation plans, protocols, risk assessments, and reports for global distribution.
- Oversee external qualification and validation packages provided by contract manufacturing organizations (CMOs) to ensure adherence to corporate standards.
- Perform validation impact assessments for change controls, deviations, audit findings, and corrective actions (CAPAs).
- Support process validation and continued process verification (CPV) strategies for outsourced products.
- Represent the organization as a technical expert during health authority inspections and internal quality audits.
- Collaborate with cross-functional core teams to ensure validation milestones are met within project timelines.
- You have 8+ years of experience in validation and qualification, with a focus on equipment qualification, requalification, and shipping validation.
- You possess expert knowledge of the Validation Lifecycle Approach and risk-based validation methodologies.
- You bring extensive experience working within cGMP, ISO 13485, and MDSAP regulatory frameworks.
- You demonstrate strong interpersonal, negotiation, and project management skills to lead complex cross-functional initiatives.
- You are fluent in English with excellent written and oral communication skills.
Nice to Haves
- Strong digital proficiency and experience with automated validation tools.
- Experience acting as a process owner within a global community of practice.
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