- B.A. or B.S. degree (preferably in Engineering or Life Science) and at least two years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.
- Basic knowledge of engineering principles and concepts applicable to Process as they relate to system performance, regulatory agency.
- Some Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA), is preferred.
- Ability to work collaboratively in cross-functional teams to achieve milestones and goals.
- Basic knowledge of EU and US CGMPs and applicable validation guidance.
- Ability to make sound decisions about quality and technical subjects.
- Ability to communicate clearly and professionally both in writing and verbally.
- Provide technical review and approve validation deliverables ensuring proper study design and execution.
- Maintain the compliance status of the assigned validation areas at a state of inspection readiness.
- Working with multiple functions, leading solution of validation issues following cGMP regulations and the client's standards.
- Site Quality technical and regulatory subject matter expert and technical leader for validation study methods, design, and regulatory requirements.
- Provide Quality Assurance oversight to Validation, Revalidation, and Quality Risk Management projects to meet good business practices and the requirements of applicable Health Authorities.
- Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.
- Provide technical review and approve validation deliverables ensuring proper study design and execution.
- Maintain the compliance status of the assigned validation areas at a state of inspection readiness.
- Working with site and corporate level functions, serve as the Quality representative in the design and implementation of area and cross-functional projects and initiatives.
- Support the validation program during regulatory agency inspections.
- Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
- Be accountable for behaviors as described in the client's Competencies.
- Provide input into the design and presentation of validation performance metrics.
- Must be able to work independently and organize and manage projects by demonstrating progress against defined milestones and schedules.
- Provide Quality oversight (including technical requirements and regulatory expectations) of site validation efforts.
- Review and approve validation documents (e.g., Project Plans, User Requirements, Protocols, Validation Deviations, Summary Reports, etc) for CGMP and technical content.
- Provide technical guidance for study design including sampling plans, acceptance criteria, and rationale.
- Provide technical and quality validation assessment and approval for engineering and process changes.
- Collaborate with departments to ensure validation activities are executed compliantly, with efficiency and effectiveness.
- Review, assess, and approve Quality Risk management documents.
- Participate in the risk stages of procuring new equipment.
- Collaborate with departments to ensure risk management and validation activities are executed efficiently and effectively.
- Review and approve Alarm Review documentation.
- Provide input into investigations with potential validation impact.
- Provide input and collaborate with other site/functional units and Corporate on validation standards and procedures.
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