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One of our global Pharmaceutical clients is looking for an experienced QA Specialist to join their team for an 11-month contract role with the opportunity to extend. The site is a state-of-the-art, 200,000 sq ft vaccines and biologics facility focused on formulating and filling vaccine and biologic products that improve and transform the lives of people across the world.
- Responsible for ensuring that the process for the manufacture of drug product is in compliance with cGMP and the associated regulatory requirements.
- Ensure that quality issues are identified, addressed and resolved before activities commence.
- Responsible for supporting deviation and atypical closeout and initiating/following up on corrective and preventative actions.
- Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
- Support the development and implementation of improved quality reporting measures.
- Aid the effective implementation of the Quality Management System, and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis.
- Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same.
- Actively participate in Plant/Quality committees and works with other site functional groups.
- Partner with colleagues cross functionally to provide support and advice on day to day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, customer queries etc.; thereby ensuring department is audit/inspection ready.
- Primary degree in scientific discipline
- Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing GMP setting.
- Experience of Sterile manufacture preferred.
- Knowledge of EU/US quality related pharmaceutical regulations
- Minimum of 5 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or manufacturing roles
- Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements
- Knowledgeable in Industry Best Practices for quality and compliance related topics.
- Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and Compliance functions on global and local level
- Proven ability to effectively initiate and drive change across the site
- Strong verbal and written communication skills, project management skills.
- Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
- Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
Quality Specialist - Global Pharmaceutical Company - County Tipperary - 11 month contract Our Partner in the Tipperary area develops and supplies the active ingredients and final formulated product
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