applications
Quality Validation Engineer
by Martin O'Leary in Waterford
Quality Validation Engineer |
Position Summary : Management and support of day to day Quality related activities Tracking and close out of CAPA, Deviations, Change control, Internal Audits, and Complaints Continuous monitoring and development of the plant quality assurance effort ensuring the needs of the customer, regulators and business are fully satisfied. |
Principle Job Responsibilities/Outputs : § Quality lead on process/equipment projects. § Ensure execution of validations in accordance to regulatory requirements and global directives. § Maintenance of established Quality Systems including, Directives, CAPA, Internal Audit, External Audit, Documentation control, New Product Management, Change Control, Regulatory systems maintenance. § Provide direction on all quality assurance matters within applicable business unit on a day to day basis. § Evaluation of established process quality controls / methods for improved efficiency § Conduct problem solving, investigation, root cause and risk reduction analysis across processes. § Drive quality and cost improvement initiatives § Work in partnership with Operations and Process Engineering to drive quality and cost improvement initiatives. § Ensure quality systems are robust to ensure acceptable product quality is produced and released. |
Key cGMP Responsibilities : § Follow Standard Operating Procedures at all times. § Ensure full awareness to the required Regulatory standards § Ensure compliance to the QMS. § Understand and follow Personal Hygiene Rules as defined in the GMP Training Programme and notify area supervision of any health conditions which may affect the quality of product. § Participate fully in all GMP and operational training programs and complete all Training Records in an accurate and timely manner. § Maintain the work area in a clean and tidy manner at all times. |
Qualifications/ Training / Experience required : § Third level qualification, ideally in Engineering or Science. § 5-7 years overall experience in Healthcare or pharma industry § Experience of validations in a dynamic, multi-task operational and cGMP manufacturing environment § Experienced in Facility/Utility/Equipment Qualification & Process Validation § Knowledge of the regulatory requirements. § Have solid background in working with key elements of a Quality System § Strong Statistical ability disirable § Knowledge of Six Sigma and Lean tools is desirable § Strong verbal and written skills § Decisive, good communicator, self-motivated, have record of achievement and be a good team member. § Computer literate § Ability to manage multiple priorities |
Please forward c.v in the strictest of confidence to Martin O'Leary moleary@brunel.ie or call on 051-309652 for further information |
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