Overview:
Morgan McKinley are proudly partnering with a leading pharmaceutical company who are seeking a Quality Specialist to support ongoing manufacturing and projects. This opportunity is a 16 month, hourly rate contract offering a competitive rate and opportunity to develop your skills set across Quality. You will join a well established team, working onsite 3 days per week Monday - Friday. This role is a QA Specialist II, in the QA Department, under the QA Manufacturing and Facilities Support team. This specific role is required to perform QA review of manufacturing and engineering records & associated documents and QA review & approval of procedures and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods and procedures
Job Responsibilities;
* Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
* Reviews routine manufacturing and engineering documentation including batch manufacturing records
* Assists in the completion of Manufacturing related customer complaint investigations
* Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
* Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
* Review and approval of GMP Deviation investigations and CAPAs
* Identifies problems and generates alternatives and recommendations
* Completion of routine/non-routine to more complex projects/assignments
* Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP
* Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings
* Normally receives very little instruction on routine work, general instructions on new assignments
Typical Education & Experience:
* 4+ years of relevant experience in a GMP environment related field and a BS.
* 3 + years of relevant experience and a MS.
If you are keen to further develop your career with a leading pharmaceutical company while working with a highly collaborative team please reach out today to hear more about this exciting opportunity. For More information please contact Ben Shanahan 021 2300446/
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
