Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety, and quality requirements.
Validation Specialist Job Description Template
Our company is looking for a Validation Specialist to join our team.
Responsibilities:
- Ensure highest Quality, Compliance and Safety standards are adhered to;
- Recommend technical approaches in line with global and local standards;
- Collaborate with validation contractors to support commissioning and start-up activities;
- Protocol/report authoring/execution/oversight/approval as appropriate;
- Support validation activities including contribution to the defining of validation requirements;
- Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise;
- Supervise validation testing performed by vendors to ensure work is complete and accurate;
- Ensure supply of high quality product through ensuring equipment availability; work with continuous process improvement initiatives;
- Be involved with in the implementation of a risk-based approach to the validation of systems in accordance with EU GMP guidelines.
Requirements:
- Qualifications related to validation and quality compliance (HMP/ICH/FDA/USP guidelines/polices);
- Experience of collaborating successfully with validation teams and a network of external contractors;
- Experience of validation in biopharmaceutical products or a combination of validation and engineering/commissioning experience;
- Being a member of a recognised professional body is desirable.