Validation Specialist
4 months ago
The validation team at Seqirus are looking to recruit a validation specialist to work within the Liverpool site validation team to support routine qualification and requalification activities, in accordance with site and regulatory standards.
The role involves leading and performing small to medium size validation activities by writing, reviewing, approving, and executing documentation for new and recurrent validation activities. Generating validation technical reports related to systems, products and/or processes, in compliance with company standards and regulatory requirements.
- Co-ordination of validation studies - ensuring pre-requisite activities are completed, required resources and support functions are available to execute the tasks.
- Maintain the validated status of facilities, equipment, and processes, by fulfilling re-validation and re-evaluation requirements, and be responsible for VMP maintenance in nominated areas.
- Provide technical leadership and investigate/troubleshoot problems. Conduct statistical analyses of testing results and process anomalies and ensures that corrective measures meet acceptable standards.
- Assist with establishing, updating, and reviewing local and global validation procedures.
- Assists in developing programs and maintaining standard operating procedures (SOPs)
- May provide support related to management of procedural documents, the Learning Management System (LMS) and GxP training
- Communicates cross functionally regarding needs and status of assigned study activities and project deliverables
Experience Requirements
- Proven quality/validation experience in pharmaceutical manufacturing
- Specific experience in qualification of facilities, equipment (manufacturing and QC testing), computerized systems, autoclaves/steam systems, utilities, and processes (including cleaning, stage 2 PPQ and aseptic simulations) would be desirable.
- Understanding/knowledge/practical use of applicable cGxP and validation/qualification regulatory documents and industry standards including Eudralex, CFR, ISO, PIC/S, BS, WHO, PDA and ISPE would be desirable.
Education Requirements
- Bachelor’s degree in engineering, mathematics, or a relevant scientific discipline (chemistry, biology, microbiology, etc.)
Our Benefits
CSL Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the
benefits
you can participate in when you join CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL
Seqirus
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about
Diversity & Inclusion
at CSL Seqirus.
Do work that matters at CSL Seqirus
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