Cork: +353 21 4509200 | Dublin: +353 1 5175910
jobs my account call
Search Jobs

QA Associate

Quality & Laboratory
Siobhán Lane
Favourites Share with a friend
Job Reference: JO-2007-65285_1594278893



* Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives

* Review and Approval of electronic and paper production batch records

* Daily presence and support on the manufacturing floor

* Release of Raw Materials for production

* Support the Technology Transfer of a new product into the site including raw material and supplier qualification.

* Support quality systems on site

* Review and approve new or updates to standard operating procedures (SOPs) and master batch records

* Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.

* Review and approve Change Control documents

* Assist with regulatory inspections.

* Support the following activities, as appropriate: Document Control, New or updates to relevant quality agreements, Process and Cleaning Validation activities, Continuous Improvement/Lean initiatives

* Compile and present metrics

* Other duties as assigned


* Minimum 4 years' relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance.

* Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.

*Experience and ability to work cross functionally

* Experience in supporting manufacturing operations and batch record review is highly desirable

* Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.

* Ability to comprehend technical information related to equipment, processes, and regulatory expectations.

* Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

View more Jobs in Quality & Laboratory
Share this job with a friend:
Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
Ask a question about this job
More jobs from Siobhán Lane >
View more Jobs in Quality & Laboratory
Share this job with a friend:
Website Design by Dmac Media