Kenny-Whelan (a specialist division of the CPL group) are hiring a QA Specialist rep for MES to work on contract at our US Global Biopharma site in Dunderrow Co. Cork.
Contact Jenn Dinan on 0214665408 or email ******.
Eligibility Requirement: MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE REPUBLIC OF IRELAND - i.e., have a valid work permit with 12 months permission + on it.
Main Purpose and Objectives of Position: Provide Quality leadership, direction, and governance for MES and MES related systems.Investigate and troubleshoot issues relating to MES and MES related systems.Manage Quality-related matters specific to the area (Quality system or Quality Program) of responsibility.Approve appropriate quality-related documents. An approval signature confirms that company and GMP requirements have been met.Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices and promptly report any safety concerns.Promote and encourage Quality culture and promptly report any compliance concerns.Scope: MES and MES related systems.
Educational Requirements: May hold BSc, MSc or PhD in Chemistry, Engineering, or related discipline.
Key Responsibilities: Provide Quality direction and oversight for MES systems.Participate in quality meetings keeping the group updated on initiatives within the QA owned GMP MES systems.Contribute to the Quality Plan (GMP Plan) for specific Quality System/ Programme Initiatives.Provide backup cover in the case of absence for any identified roles.Assure consistent implementation of standards across the Quality System.Assure that the Quality system(s)/Program remains in a validated state and aligned within regulatory commitments.Interpret and apply emerging Regulatory & GMP guidelines to the specific Quality System(s)/Program.Support audit logistics from an MES perspective.Support cross-functional teams in audit preparation activities.Carry out audit trails reviews as per site procedures.Liaise with Global Quality Standard owner when deemed necessary.Benchmark current and emerging initiatives in the specific Quality System(s)/Program.Assess the Quality Impact of quality events associated with the area(s) of responsibility.Review and approval of change controls, deviations, failure investigations, if applicable.Report and escalate critical quality issues to the appropriate level of quality management for resolution.Review and approval of key GMP documents such as GMP standard operating procedures and CSV deliverables as appropriate to area of responsibility.Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facilities, equipment, computer systems, GMP utilities and system periodic review reports as appropriate to area of responsibility.Participate in the site self-inspection program of the area(s) of responsibility for compliance with the GQS & local procedures.Monitor GMP compliance, GMP programs & systems by ensuring a regular presence in area of responsibility.Communicate and educate personnel in GMP requirements and regulations related to the area(s) of responsibility.Key Attributes: Excellent attention to detail.Experience working in cross-functional teams and proven ability in decision making.Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.Strong organisational skills, including ability to follow assignments through to completion.Strong understanding of Data Integrity and its applications.Self-motivated, positive and ability to work under pressure.Demonstrates flexibility and adaptability to meet business needs.Excellent interpersonal and communication skills (written and oral).Demonstrates a continuous improvement mind-set.Demonstrated initiative – able to work proactively without direct supervision, continuous improvement mind-set.Confidentiality: All applications will be treated with the strictest of confidence.
Contact Jenn Dinan on ****** or call 0214665408.
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