Senior Quality Assurance Specialist is required for a South Dublin based Biopharmaceutical company that specialises in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. In July 2015 the site opened a $300million investment, which added significantly to the sites laboratory, filling, packaging and distribution (including cold chain) capabilities. The site is a fast paced, collaborative, team based working environment, where you get an opportunity to work with other highly skilled staff in a strategically important site in the companies global supply chain.
As Senior QA Specialist you will:
-Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
-Write, review and approve Standard Operating Procedures.
-Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations.
-Act as Quality point of contact and decision maker during Technology Transfer and Process Validation activities whilst ensuring that all activities meet internal and regulatory expectations.
The Quality Assurance Specialist (Senior) will require:
-3rd level degree. Engineering or Science related discipline preferred.
-Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry
Call Mairead in LSC on 0214777 329 to discuss this Senior QA Specialist role in more detail or apply directly via this advert.