Job Title: Assurance Expert
We are seeking a skilled professional to assume the role of Quality Assurance Specialist and join our esteemed Pharmaceutical organization in Dublin.
Key Responsibilities:
* As the primary point of contact for Quality, you will oversee New Product Introductions, Technology Transfer, and Process Validation activities for Aseptic products, ensuring seamless execution and compliance with regulatory standards.
* Review and approve Process Development and Validation documentation, including Technical transfer documents, Validation Protocols, executed validation documents, and reports.
* Provide expert guidance and oversight at Change Control and Deviation Review Boards, ensuring the scope of records is clear and implementation activities are robust and timely.
* Maintain all activities in adherence to strict safety standards and SOPs.
Educational Requirements:
* University degree, preferably in an Engineering or Science related discipline.
* Relevant experience (7 years+) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
* Deep understanding of principles of Validation and New Product Introduction.
* Proven expertise in aseptic manufacturing.
Benefits and Opportunities:
* Excellent opportunity to work with a leading multinational company.
* Professional growth and development opportunities within a dynamic and award-winning organization.
Guiding Principles:
* Compliance with regulatory expectations.
* Collaborative approach to work.
* Adherence to established policies and procedures.