Validation Specialist
2 weeks ago
CSL Seqirus, a global leader in influenza protection, is seeking a skilled Validation Associate to join its Quality Assurance (QA) Validation team in Parkville. As a key member of the team, you will provide validation support for process, cleaning, and equipment, as well as support revalidation activities across the Seqirus business.
The Role
You will be based on-site at Parkville but may require time at Tullamarine. Key responsibilities include:
- Performing validation activities associated with changes to existing plant, equipment, and processes, and project validation activities as determined by the Validation Project Facilitation department.
- Following the Quality Management System, Site Validation Master Plan, Business Improvement, and Validation procedures to meet the requirements of all codes, regulations, and policies.
- Preparing, implementing, and maintaining departmental documentation for validation activities and regulatory submissions.
- Building and maintaining collaborative relationships with stakeholders.
- Participating in internal and external audits, as well as problem-solving and identifying opportunities for improvement to optimize validation activities.
- Ensuring all training certification requirements are up-to-date.
- Maintaining a safe work environment in compliance with Seqirus policies, procedures, and statutory obligations.
Your Skills and Experience
To be considered for this role, you will possess a bachelor's degree in an Engineering or Science-related field, with 3+ years of experience in the Pharmaceutical Industry in a validation, quality assurance, or engineering-related role. You will have knowledge of GMP, QMS, and Risk Management, as well as experience in a role requiring cross-site collaboration and multi-tasking.
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