Quality Assurance Officer

6 days ago

Dublin, Dublin City, Ireland Phoenix Labs Full time

Phoenix Healthcare is committed to maintaining the highest standards of quality in our manufacturing processes.
Our mission is to ensure consistent GMP compliance while fostering a culture of quality awareness and continuous improvement among our staff.
About the Role
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.
Location
This is an onsite role based in Tallaght Co.
Dublin
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 Phoenix Healthcare 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 Phoenix Healthcare 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.
Skills and Education Requirements
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.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
Pharmaceutical Manufacturing
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