Quality Assurance Specialist (hybrid)
RK****
Contract 12 months
Dublin
Duties
Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet company and regulatory expectations.
Quality review and approval of Process Development and Validation documentation.
Technical transfer documents.
Validation Protocols, executed validation documents and reports.
Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
Perform all activities in compliance with safety standards and SOPs.
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
Educational and Experience
University degree.
Engineering or Science related discipline preferred.
Relevant experience (7yrs+) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
Understanding of principles of Validation and New Product Introduction.
Experience in aseptic manufacturing.
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
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