Quality Assurance Specialist
Posted on Jul 24, 2022 by Actalent
The QA Specialist is responsible for supporting operation of core Quality Systems used in the College Park 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.
The role reports to the QA Lead.
Roles and Responsibilities:
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.
Job Title: Quality Assurance Specialist
Location: Dublin, Ireland
Job Type: Contract
Trading as Aerotek and Actalent Services. Allegis Group Limited, Bracknell, RG12 1RT, United Kingdom. No. . Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website.
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