PE Global are currently recruiting for a Quality Specialist – Quality Systems for our client site in Tipperary:
11 month initial contract
Role Description
The Quality Specialist – Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product facilities. The Quality Specialist participates as a member of the Quality Systems Team.
Role Functions
(Functions include, but are not limited to, the following)
The incumbent ensures timely and effective completion of the Quality Systems core functions in accordance with schedules and policies, procedures and guidelines, including:
Sub System Ownership:
* Complete sub system ownership responsibilities as per the site System Ownership list.
Quality SME for Process, Cleaning, Water, Equipment
* Provide leadership through knowledge and skill regarding validation standards for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
* Participate in and support site validation committees such as PVC, WVC, CVG, and EQVC.
* Approve validation documentation ensuring compliance and maintain validation status following changes.
* Support validation requirements for site or capital projects, providing technical assistance as part of project teams.
* Develop Validation Summary Reports and assist in creating overall Quality plans for major projects.
* Collaborate with industry and internal teams to predict validation trends and best practices.
* SAP Quality Process Steward.
Quality SME for Change Control
* Serve as the principal Quality contact for all site change requests impacting processing, reviewing all change requests for compliance and quality assessment.
Laboratory QA oversight
* Support and approve systems supporting laboratory functions, instrumentation, and GLIMS.
* Review and approve laboratory incidents, investigations, and documentation.
* Oversee stability reports, ensuring accuracy and supporting investigations as needed.
* Act as Microbiology Point of Contact for microbial issues related to water, utilities, environment, or product.
Quality Agreement System Management
* Manage site Quality Agreements, ensuring they are current, approved, and properly filed.
Annual Review System Management
* Ensure completion of Annual Reviews (AR/APR/PQR) for products and systems, including automation.
Documentation and Regulatory Support
* Review and approve site Quality documentation, including Site Master File, Validation Master Plan, policies, and procedures.
* Support site application User Access Reviews and ensure compliance.
Quality Council
* Manage the schedule, agenda, minutes, and actions for the Quality Council meetings.
Supplier and Customer Interactions
* Review and approve Supplier Change Evaluations and related documentation.
* Participate in investigations of customer and supplier complaints.
Regulatory and Compliance
* Maintain site licenses and support regulatory requests and filings.
* Review documentation for regulatory submissions ensuring data integrity.
Additional Responsibilities
* Manage Returned Goods segregation and disposition.
* Support internal GMP audits and regulatory inspections.
Special Features
* Operate as part of a self-directed team, monitor performance metrics, participate in initiatives, and promote GMP awareness.
Experience, Knowledge & Skills
* Knowledge of MMD and site quality policies, GMP standards, and validation principles.
* Understanding of plant procedures, equipment, and documentation.
* Familiarity with Laboratory testing, validation, and system development lifecycle.
Qualifications & Education
* Degree or postgraduate qualification in Science, Pharmacy, or Engineering.
Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey on 021-4297900, or send an up-to-date CV to audrey.mccarthy@peglobal.net.
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