Quality Assurance Analyst

Job Overview


Currently I am seeking a QA Specialist for a much sought after employer in the pharmaceutical, manufacturing industry, Ringaskiddy, Cork .

The QA Specialist job will be responsible for review and approval of change controls, non -conformance investigations, and protocols.
Min 2 years relevant experience required in a QA job, preferably within a pharmaceutical manufacturing environment.
Contact Felicity 086 7821714


QA Specialist Job

Duties:
· This QA Specialist Job will be responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation related to Pharmaceutical projects
· Activities include review and approval of change controls, non-conformance investigations, and protocols.
· Support the management of GMP compliance systems
· Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
· Carries out tasks related to the administration of project and site non-conformance management systems:
· Reviews and/or approves non-conformance investigations and their associated documentation.
· Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
· Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
· Approves closure of non-conformance investigations on completion of the investigation and associated corrective actions.
· Carries out tasks related to the management of project and site change control systems:
· Reviews and/or approves change control requests, implementation actions, and request closures.
· Manages entry of change control records into the appropriate electronic system.

Requirements
· Bachelor's Degree in a scientific/technical discipline
· Min 2 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
· Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
· Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the QA specialist job

Apply with an up to date CV in Word format via the link, contact Felicity 0867821714

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