We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
The QA Specialist is responsible for supporting operation of core Quality Systems used in the Drug Substance Manufacture Facility and providing QA support to both manufacture operations for drug substance and to laboratory operations for drug substance and drug product testing.
•Activities will include Maintenance of Quality Systems including Training, Change Control, Deviations, CAPA, and Supplier qualification. QA review and assessment of QC data including investigations, out of specification and unplanned events will form a key part of this role.
• Support the management of Quality Management systems including Change Control, deviation and CAPA Modules.
• Support Quality Control investigations, out of specification and unplanned events workflows to ensure they are performed correctly, assist in Root Cause Analysis investigations as required.
• Support change control management process ensuring impact of proposed changes are adequately assessed how the implementation is managed, includes. Change Review Board meeting lead, Task/Action approvals & Final Change reviews.
• Support the Generation and execution of Management review on site.
• Responsible for the management of GMP training and to foster a quality led culture across the new site.
• Assist with preparation and execution of back-room activities for Health Authority Inspections, in addition to Health Authority visit preparation projects.
• To manage the implementation of process improvements in line with the QMS.
• Ability to exercise judgment with defined procedures and practices to determine appropriate action.
• Accountable for completing activities within required timelines.
• Proactively highlight any issues around compliance.
• Willingly accepts challenging assignments.
• Engage with and Support Continuous improvement activities on site.
• Review and reporting of onsite metrics as required.
Education & Experience
• Bachelor’s Degree in scientific/Quality discipline with 3 years’ experience working as a QA Specialist or Quality System specialist in Pharmaceutical Manufacture Facility.
• Experience working with Quality Systems such as Deviations, Change Controls, Training, Supplier Qualification and Document Management systems required.
• Good interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• Must be able to function effectively in a teamwork environment.
• The individual must demonstrate an ability to work independently.
• Thorough, diligent, good attention to detail
• Collaborator with strong levels of engagement with individuals and team
• High level of delivery and work completion
• Strong organizational skills.
• Proficient with Excel and other Microsoft packages.
• Experience with Electronic QMS (Trackwise or equivalent)