LSC requires a QA Associate for our leading edge biotech client based in Cork.The QA Associate reports to the QA Manager, and is responsible for supporting site quality systems, site start-up, inspection readiness and assisting with the batch release process for drug substance.
The QA Associate will be responsible for:
-Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives
-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 standard operating procedures (SOPs) and master batch records.
-Review and approve deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
-Assist with internal audits to ensure compliance with cGMPs and other regulatory requirements.
-Assist with regulatory inspections.
-Support the following activities, as appropriate:
–New or updates to relevant quality agreements
–Annual Product Reviews
–Complaints, recalls and/or notification of events to regulatory agencies
–Other duties as assigned
Experience and Qualifications:
-Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
-Minimum 5 years’ relevant experience in a cGMP regulated manufacturing and packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
-Strong ability to communicate, present data, and defend approaches in front of audiences and inspectors.
-Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
-Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
-Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
To discuss this role further please call Kathy at LSC on 021 4777329 or apply directly through this advert.