Quality Assurance

Role Summary:

• We are seeking a Quality Assurance Officer to join our client’s pharmaceutical site in Co. Dublin.
• The QA Officer will work within a multi-disciplinary team to take a tactical role in the design, implementation, and establishment of suitable governance processes to assure the consistent GMP compliance of the GMP manufacturing facility.
• This is a fixed term contract based on site.

Core Duties and Responsibilities:

• Provide general quality subject matter expertise for the facility operations.
• Promote the awareness of quality requirements and support the evolution of the quality culture throughout the company and educate staff in quality related activities where appropriate.
• Maintain processes, including GMP document control (i.e. Batch review, issuance of document) and training, needed for successful site compliance to the PQS.
• Participate in the review performance of the PQS at planned intervals and provide regular reporting to ensure its continuing suitability, adequacy, and effectiveness and where appropriate, propose improvements.
• Participate in the execution of a GMP internal Audit/self-inspection programme, including identification and implementation of appropriate corrective actions and the process to track their completion via the change management system.
• Monitor and coordinate completion of GxP Audit PQS records (i.e., change controls, deviations and CAPAs) maintained on electronic Quality System.
• Provide compliance support by providing advice and facilitating the escalation of compliance issues through the appropriate routes via the PQS.
• Work with other elements of the QMS and the QA team as required to support site compliance, business KPIs, and continuous improvements.
• Administration of the Quality Management System including allocation of document numbers, event numbers and maintenance of the associated logs.
• Act as a QA Archivist, ensuring the safe retention of the company’s quality records, ensuring the appropriate storage of GMP documentation.
• Ensure company compliance of Good Documentation Practices, maintenance of signature logs and company initials register.
• Notify document owners in a timely manner of pending SOPs/forms requiring review and track progress until completion.
• Responsible for issuance, obsolescence and archiving of the QMS documents.
• Creation, review and approval of Quality documents.
• Facilitate all departments across site to maintain compliance within the use of the quality systems through providing training, auditing, project risk assessments and be the primary contact to support GMP/GDP related activities across the manufacturing and warehouse sites.

Minimum Qualifications and Experience:

• Excellent communication skills
• BSc or equivalent in scientific discipline
• Understanding of GMPs and GDPs
• Ability to manage multiple and varies tasks and prioritize workload with attention to detail
• QA experience working within a GMP setting.
• Ability to apply risk-based approach for pragmatic problem solving.
• Strong organisational skills
• Professional handling of all internal and external communications with regards to quality.
• Strong time management for the control of self-workload.
• Good team player.
• Flexible in supporting business needs.
• Uses initiative to drive improvements.
• Proactive, enthusiastic, resourceful and results orientated.

Please note, we do not require agency assistance with this role.