Kelly Services is currently recruiting a QA Specialist for our Global Pharma Client in Co. Cork.
You will work as a QA Specialist under the QA Quality Monitoring team.
This is a 1 year contract initially with excellent opportunities within this Global Organisation to come permanent.
You will be required to perform activities such as Annual Product Quality Reviews, Customer Complaint Investigations, Counterfeit Sample Assessments, QA Review & Approval of Procedures and Metric Gathering.
This position requires a sound knowledge of quality assurance systems, methods and procedures.
You will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes.
Essential Duties and Job Functions:
* Participates within inter-departmental and cross-functional teams
* Authors Annual Quality Review site contributions and co-ordinates with global team
* Perform Counterfeit Assessments for Product Complaints
* Perform Customer Complaint Investigations
* Perform Metric gathering
* Participate in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
* Perform walk through's on behalf of the QA department to ensure site compliance to GMP
* Work on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.
* Exercise judgment within defined procedures and practices to determine appropriate action
* Normally receives very little instruction on routine work, general instructions on new assignments
Knowledge, Experience and Skills:
* Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
3+ years of relevant experience in a GMP environment related field and a BS.
* Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
* Demonstrates working knowledge of quality assurance systems, methods and procedures.
* Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
* Demonstrates audit and investigation skills, and report writing skills.
* Good verbal, written, and interpersonal communication skills.
* Proficiency in Microsoft Office applications.
Kelly Services are acting as an Employment Business in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.