Permanent - Blanchardstown area.
A vacancy now exists for the role of QA Specialist reporting to the Quality Manager. This is a Full Time-Permanent position, and the purpose of this role is to work within a cross functional environment to foster an ethos and culture of cGMP & Quality awareness.
Principle Accountabilities include but are not limited
· Leading site cross-functional Kaizens and continuous improvement initiatives from conception to closure, with specific focus on Quality and Laboratory driven improvements.
· Participate in Quality Management System Harmonisation activities.
· Manage the calibration of GMP Service Providers in QC Laboratory
· Responsible for completion of Data integrity admin checks
· Represent Quality in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigations and problem resolution.
· Complete batch record review and perform API Product Release.
· Prepare, review data & reports including quarterly and annual product quality review reports.
· Participate in the Internal Auditing program.
· Participate in the Supplier Management program.
· Lead method development and validation initiatives.
· Edit, review and approve GMP documents.
· Ensure that EHS roles and responsibilities are complied with as per the requirements of the site Safety Statement.
· Perform other related duties as assigned from time to time based on company needs.
Required Skills & Background
· Applicants must have the following:
· Bachelor’s Degree in Science or related pharmaceutical discipline
· Minimum of 3 years’ experience working in a cGMP role in a pharmaceutical environment.
· Desirable evidence of Continuous Professional Development.
· Understanding of EU GMP Complexity.
· Good organizational skills and attention to detail.
Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
Ability to prioritize, manage multiple tasks, and meet deadlines
For a confidential discussion on this role, reach out to speak with Aisling Murray firstname.lastname@example.org or on 087 4671309.