QA Specialist Systems
|Job Title:||QA Specialist Systems|
|Contact Name:||Laurentina Kennedy|
|Job Published:||about 2 months ago|
The Quality Assurance Specialist will ensure that excellent standards of quality are maintained throughout the business processes and the standards are continuously monitored and improved.
The key areas of responsibility lie within the areas of Quality Assurance, Quality Control and Auditing.
Reporting to: The Scientific & Medical Affairs Manager
You will be reporting into the Scientific and Medical Affairs Manager but will work closely with other roles within the Quality Department and Regulatory/Pharmacovigilance, Research & Development and Supply Chain.
Ensure that continues to operate in accordance with European GMP/GDP regulations for drug products, the Medical Device Directive and ISO regulations for medical devices, and any other relevant guidelines related to business.
Preparation and updating of company SOPs.
Ensuring that internal and external QA documentation is prepared and completed correctly as per the regulations and company SOPs.
Assist with the preparation of Technical Agreements with all relevant suppliers.
Controlling and maintaining the document archive and sample retention system.
Maintaining systems relating to QA, including change control, deviations, CAPA, complaints, audits and vendor approval.
Generation and reporting of Quality metrics.
Logging product complaints, follow up with suppliers on investigations in conjunction with the Manufacturing Specialist and close investigations within agreed timeframes.
Updating and maintenance of Quality documents e.g. product specifications.
Maintain the stability programme including scheduling, ensuring testing is completed, results are reported on time and any out of specification results investigated.
Assist with the preparation of the Quality Management Reviews and Product Quality Review.
Assist with the preparation of in-house training and external training.
Co-ordinate the dispatch of samples to contract laboratories.
Ensure complete documentation of testing of products at contract laboratories.
Perform QA checks on documentation prior to the release of products for sale.
Preparation and checking of Certificates of Analysis.
Coordinate internal audits, carry out internal audits and ensure the review, monitoring, reporting of the inspections. Ensure audit action items are closed within agreed time frame.
Assist with audits and checks on suppliers and ensure the review, monitoring and reporting of the audits.
Assist with preparation for Health Authority and Notified Body inspections and prepare regulatory inspection responses.
Facilitate inspections by Third Parties.
Provide administrative and/or technical support with respect to preparation, assembly, filing and distribution of information relating to product registrations, compliance and pharmacovigilance.
Assist with the maintenance the product technical files.
Prepare regular Quality Management System updates.
Ensure that training plans are implemented and training records are maintained.
Perform other tasks as will be required from time to time.
3rd level qualification in a science discipline.
3 to 5 years of experience in the medical devices and/or pharmaceutical industries. Specific experience working in a quality system or quality assurance role is a requirement for this position.
For further information on this QA Specialist position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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