Job Description:
Accountable to the
Senior QA Engineer.
Resolve and assist in the closure of deviations initiated during production and follow up in the Cordis Quality System (QSNC/QNC) as required.
Participate in the development and implementation of the manufacturing processes for existing and new products. Review and approval of process and equipment validation/qualifications (IQ, OQ, & PQ) including the inspection and sampling plans.
Responsible for the Development and implementation of process sampling plans, procedures and statistical techniques; and specification of inspection and testing procedures to support start-up of facility.
May conduct training on quality assurance concepts and tool.
Interfaces with the project teams on quality system related issues.
Support 2 shift cycle pattern. Mon Fri: 8.00 16.00, 16.00-00.00 Shift may be longer and include Saturdays at company discretion.
Roles / Responsibilities:
¿ Resolve and assist in the closure of deviations initiated during production and follow up in the Cordis Quality System (QSNC/QNC) as required.
¿ QA input (review and approval) for Process Development activities eg. Characterization Studies, Optimization Studies, Test Method Validation etc.
¿ Support preparation, review, approval and execution (where applicable) of site related documentation (Transfer Strategies/Plans, Design and Development Plans, DPs, MWIs, QWIs EO Packages etc.)
¿ Ensure output of studies are incorporated to relevant commercial documentation.
¿ Recommend Process Improvements.
¿ Implement, deploy and revise as applicable Cordis Franchise procedures.
¿ Conduct Staff Training (Design Policy, Review, Risk Management, Verification / Validation).
¿ Generate SOP¿s/other documentation as applicable.
¿ Knowledge and adherence to all of the applicable Corporate and Company policies and in particular the Quality and HSE Policies.