Senior. QA Compliance Engineer
The Senior QA Compliance Engineer will assist with the supervision of the site Quality Management System as directed by the Head of Quality.
·   Responsible for team management and problem solving and actively promote best practice in quality methods and continuous improvement
·     Provide project management leadership to ensure effective planning and timely execution of all process improvement and new product introduction projects.
·      Team management and ensuring compliance with current EU GMP and US FDA guidelines.
·   Responsible for review, investigation & approval of Product/Customer Complaints in a timely manner.
·       Manage, maintenance & approval the Change Control, Deviation & CAPA systems in accordance with the relevant SOPs & ensure timely close-out.  Acting as Quality representative on the site Change review board and Quality review board when appropriate.
·     Oversee the validation master plan ensuring processes, procedures and systems are valid.
·        Oversee new product introduction and associated risk assessment.
·        Drive timely execution of investigations/risk assessments for same.
·       Approval of the Internal Audit Schedule ensuring timely execution including reporting and close out of all issues.  Conduct internal audits where appropriate.
·        Liaising with suppliers and customers when required.
·        Review and approval of Technical Agreements when required
·    Quality approval of GMP documentation SOPs, validation protocols and reports, manufacturing document for Chanelle/contract manufactured products, PQR reports, rejection notices, Operating procedures & QMS documents.
·   To coordinate and participate in third party audits (customer and Regulatory).
·    Training of new/updated processes where required.
·          Bachelors degree in a science-based discipline with a minimum of 6 years experience in a pharmaceuticals manufacturing environment with working knowledge of EU GMP and US FDA Guidelines
If you are interested in this role as a Senior QA Compliance Engineer, please click on the apply button and send us your CV"
You can also contact our office on 093 41932 to discuss this opportunity in further detail
"If you would like to learn more about our company please visit our website" www.bdr.ie