A QA Specialist is required on an initial 16-Month basis by CareerWise Recruitment for our Cork-based multinational research-based pharmaceutical Company.
This role is a contract position in the GSIUC QA Department, under the QA Quality Systems team. This specific role is required to perform activities such as Annual Product Quality Reviews; management, collation and processing of Regulatory Requests submitted to GSIUC QA; Review & Approval of Deviations/Change Controls/Procedures, support the updates and site for quality systems processes such as deviations, change controls, data integrity and QRM; drives improvements to the QMS processes; QA Review & Approval of Deviations/Change Controls/Procedures, health authority inspection and corporate audit support, Deviation facilitation, site manufacturing licence/site master file updates and metric gathering. This position requires a sound knowledge of quality assurance systems, methods, procedures, critical thinking and excellent communication skills. The candidate 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. The candidate must be proactive in their daily activities and interactions.
THE ROLE:
- Participates within inter-departmental, cross-functional & cross site teams
• Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
• Management, collation and processing of Regulatory Requests submitted to GSIUC
• Authors Annual Quality Review site contributions and co-ordinates with global team
• Assist with investigations and corrective and preventive action (CAPA) relating to quality systems.
• Performs metric gathering and critically assesses the data for emerging trends.
• Working directly with personnel to drive improvements to the QMS processes
• Giving site training on QMS elements
• Deviation facilitation
• Backroom support for Health Authority Inspections and Corporate audits
• Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/ Deviations/Change Controls and other types of controlled documents
• Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP
• Works on assignments that are routine in nature, where ability to recognize deviation from accepted practice is required.
• Exercises judgment within defined procedures and practices to determine appropriate action
• Normally receives very little instruction on routine work, general instructions on new assignments
REQUIREMENTS:
• 6+ years of relevant experience in a GMP environment related field and a BS.
• 4+ years of relevant experience and a MS.
• Prior experience in pharmaceutical industry (ideally within a QA role)
• Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
• Demonstrates advanced working knowledge of QA systems principles, methods, QA concepts, industry practices and standards
• Maintains and develops programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
• Develops solutions to more complex problems, identifies variance from accepted practice, and evaluates impact as necessary
• Provides guidance and technical knowledge to personnel
• Good 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.
• Demonstrates strong verbal, technical writing and interpersonal skills.
Proficiency in Microsoft Office applications.
Please call Aisling O’Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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