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Quality and Validation Specialists
2 months ago
Purpose of the Role
Protect the end users of products manufactured in the compounding unit by maintaining and appropriate level of regulatory compliance. To design, effectively implement, monitor and maintain the quality management system. Ongoing management of licenses related to specials manufacture and management of Competent Authority inspections and customer audits.
Aspects of the Role
* Develop, implement, monitor in autonomy all the initiatives necessary in the perspective of ensuring a full coverage of GMP duties relevant to facility & equipment qualification/re-qualification, process/method validation including VMP support, review and approval, URS/FAT/SAT, IQ/OQ/PQ support, review and approval, regulator monitoring, tracking actual plan vs VMP schedule, KPI reporting
* Provide visibility and monitoring on local state of Compliance to the QA Manager. Develop, diffuse and promote metrics
* Provide technical input on Change Control evaluations with regards to Q&V aspects
* Support the development of the quality plans for ensuring all regulatory requirements are met during the validation of equipment, facilities, utilities or systems whether new or to be brought to the standard
* Ensure technical input and guidance on deviation investigations during qualification/validation activities in case of relevance or impact
* Identifying opportunities for improving equipment and methods
Audits:
* Provide support to the local organisation as SME and as a primary point of contact for the relevant Regulatory Agencies in occasion of Regulatory Inspections, customer audits and for the relevant follow-up
* Assist in internal and external audit program, as required. QA data review and compilation of reports
Risk Management
* Support the implementation of the risk management process and register,, ensure all process have suitable risk management in place, develop and maintain best practice in risk management with site QA and operations staff
* Responsible for maintaining risk management process as a live cycle and report the progress of the identified actions to the Quality Management Review
In addition, the role will also fulfill duties within the unit and business as a Quality Officer. These include:
* Support the tracking and trending of quality system data, including but not limited to Quality incidents, NCR's, CAPA and Complaints
* Complaints: Completing complaint investigations, Responsible for reporting any complaints that may result in Field Corrective Action immediately, Reporting any adverse events to Pharmacovigilance
* Quality Incidents: Ensure that any Quality incident is documented, Ensure that any failure to follow procedure or failure of product to meet specification is fully documented and investigated, Leading and coordinating investigations
* Corrective and Preventative Action: CAPA owner and leader, Ensure CAPA investigations are completed, and root cause identified and that appropriate actions are specified and completed according to agreed time frames, Raising supplier corrective actions to address out of specification raw material issues
Skills & Knowledge
Experience:
* Validation within a GMP environment
* Risk Management
* Working in a project-based environment
* Experience implementing changes and process development
* Previous experience in an aseptic manufacturing facility
Skills/Abilities
* Good problem solving and investigation skills
* Good professional standards, meticulous and demonstrates good attention to detail
* Ability to work under pressure and meet deadlines
* Highly motivated self-starter and team worker
* Ability to work in a team based environment and ability to manage a wide range of specific tasks
* Good organisational, coordination and communication skills
Education:
* Degree in pharmacy or life science or Engineering
* Post qualification experience of at least 2 years
* Or HNC/HND or similar and 3-5 years' experience
* Certified training as Lead or internal auditor is desirable but not essential
