A QA Specialist is required on an initial 12-month basis by CareerWise Recruitment for our multinational research-based pharmaceutical company in Cork. This role is a QA Specialist II in the GSIUC QA Department, under the QA General Operations Support team.
Job Description
This role involves performing QA review of manufacturing and engineering records and associated documents, as well as QA review and approval of procedures and GMP deviations.
The candidate will have a sound knowledge of quality assurance systems, methods, and procedures. They will 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.
The candidate must be proactive in their daily activities and interactions.
Role of this Position
* 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) and other types of controlled documents.
* Identifies deviations from accepted practices, exercises judgment to evaluate impact, and determines appropriate actions.
* Reviews and approves GMP Deviation investigations and CAPAs.
* Identifies problems and generates alternatives and recommendations.
* Completes 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.
Job Requirements
* Prior experience in the pharmaceutical industry is preferred (ideally within a QA role).
* Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA/EEMA 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.
* 4+ years of relevant experience in a GMP environment-related field and a BS degree.
* 3+ years of relevant experience and a MS degree.