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Senior Associate
2 months ago
About the Opportunity:
As a global leader in influenza protection, CSL Seqirus is a renowned organization in the pharmaceutical industry. Our Asia Pacific operations involve the manufacture and distribution of a range of uniquely Australian products, as well as the marketing of in-licensed vaccines and pharmaceuticals in Australia and New Zealand.
We are seeking a highly skilled Senior Associate - Validation Operations Specialist to join our Quality Assurance (QA) Validation team in a full-time fixed-term capacity. Reporting to the Validation Manager, you will provide validation support for process, cleaning, and equipment, as well as support revalidation activities across the Seqirus business.
About the Role:
Based on-site at our Parkville location, with occasional requirements at Tullamarine, you will:
- Plan, coordinate, and monitor validation activities associated with changes to existing plant, equipment, and processes, as well as project validation activities determined by the Validation Project Facilitation department.
- Manage validation activities in accordance with the Quality Management System, Site Validation Master Plan, Business Improvement, and Validation procedures to meet the requirements of all codes, regulations, and policies.
- Prepare, implement, and maintain departmental documentation for validation activities and regulatory submissions, including validation protocols and reports, Executive Summaries, and Validation Master Files.
- Build and maintain collaborative relationships with key partners.
- Participate in internal and external audits, including those conducted by the TGA and FDA.
- Contribute to problem-solving and identify opportunities for improvement to optimize validation activities.
- Ensure all training certification requirements are up-to-date.
- Follow documented procedures to maintain a safe work environment in compliance with Seqirus policies, procedures, and statutory obligations.
- Assist with EHS Risk Assessments and the implementation of safety improvement plans.
- Ensure the health, safety, and security of yourself and others at work.
Requirements:
To be considered for this role, you will have:
- A bachelor's degree in an Engineering or Science-related field.
- 5+ years of experience in the pharmaceutical industry in a validation, quality assurance, or engineering-related role, applying validation protocols to systems, processes, cleaning, and equipment.
- Knowledge of the manufacturing of sterile injectables.
- Knowledge of GMP, QMS, and Risk Management.
- Experience in a role requiring cross-site collaboration and multi-tasking.
- Excellent communication skills, including experience in technical writing.
- Experience with machinery and equipment.
