I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
R&D Engineer
Galway
QA Manager
Dublin West
API Purchaser
Dublin
QA Officer
Dublin
QA Manager
Meath
Head of Quality
Dublin West
Buyer
Cork
QA Manager
Dublin North
Program Manager
Westmeath
R&D Engineer
Dublin
Biostatistician
Dublin City Centre
QA Manager Biologics
Dublin West
Snr QA Specialist
Dublin South
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

Quality Assurance Officer


Reference:APFA-522406 Location: Waterford
Qualification:DegreeExperience:2-3 Years
Job Type:Temporary ContractSalary: Not Disclosed

Quality Officer

Purpose of the Job:
Our client is a large pharmaceutical company based in Waterford. They wish to recruit a Quality Officer to ensure that they are in compliance with regulatory requirements by timely review and release of batch documentation and conducting process, packing, cleaning and validation activities of all areas against the regulatory standards.

Specific Key Result Areas:
• To ensure that all work carried out is in Compliance with the required standards conforming to company, cGMP, cGLP’s, SOP’s, regulatory regulations and guidelines, H&S and environmental guidelines.
• New Product/Validation: Quality support for introduction of new products, equipment and facilities.
• To generate, review and conduct process, packing, cleaning and computerized systems protocols and validation reports in line with current regulations and industry best practice, within required timelines.
• Review and approval of change proposals and related documentation for compliance with regulatory approvals and GMP requirements. Review and assistance in Laboratory, Complaint, Vendor and Production investigations and reduction of trends in conjunction with relevant departments.
• Quality Systems Development: To develop and improve quality systems by identifying areas for improvement (NVAA’s and key variances) and take corrective action as required ensuring continuous improvement in accordance with Company Continuous Improvement Process.

Support
• To deliver Customer Service (both internal and external) through agreed timelines in accordance with quality standards and cost control.
• Participate in CI activities / projects / root cause analysis and solution implementation to enhance the product value streams.
• To conduct simulated HPRA/FDA systems inspections to ensure the company is at all times ready for audit. Conduct audits of Suppliers where necessary.

The successful candidate should possess the following:
• Qualification in a Science Discipline and work experience in Pharmaceutical/Medical Device with two years’ experience in a QA environment, preferably in a validation role.
• In depth knowledge and understanding of interpretation of CGMPs, GAMP and regulatory requirements, experience of regulatory inspections and customer audits.
• Experience in CSV and product serialisation activities would be advantageous.
• Understanding of Production and Laboratory systems to effect decisions consistent with business needs.
• Experience of combination devices/pharmaceuticals manufacturing is preferred.
• An understanding of internal/external customer requirements and an ability to respond promptly to needs.
• Ability to participate in day to day activities and projects by providing Quality support.
• Ability to work on own initiative to meet and exceed business objectives.
• Experience with TrackWise, EDMS and strong report writing skills.
• Inhalations and MDPI experience would be beneficial.



Clodagh Nerney | Tel: +353 (0) 1 507 9254