About the Company
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.
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
* 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.