Incoming QA Specialist

Pe Global

Dublin

PE Global is currently recruiting for Incoming QA Specialist for a Client site in Dublin: The Incoming Quality Assurance Specialist. Overview: The successful candidate will report to the Senior Manager of IQA (Incoming Quality Assurance) with responsibility for disposition of raw materials, vendor and contractor management, oversight of Warehouse operations, QC support, project support and change control management at the facility. Other responsibilities will include: Interfacing with Senior Management and Regulatory Inspectors, Corporate SQM (Supplier Quality Management) and other network functions. Data management, presentations and involvement with key improvement and Operational Excellence initiatives will also be required. This position requires demonstration of strong interpersonal skills with advanced communication and analytical skills. The specialist position will be responsible for ensuring that SOP’s and policies are created and maintained in line with regulatory and Operating Standards. Other duties may be assigned in line with business requirements as assigned by the Quality Director/Line Manager. Key Responsibilities: • Responsible for the review and disposition of incoming materials and components. • Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause. • Provide QA oversight for Supply Chain and QC. • Own or provide QA oversight for non-conformance records, CAPA records and change control records. • Manage the Raw Material reserve samples. • Collaborate with Global IQA and SQM networks to drive alignment and continuous improvement within the organisation. • Compile and report key departmental metrics. • Support Lean Transformation and Operational Excellence initiatives. • Write, review and approve Standard Operating Procedures in accordance with Policies. • Provides training and advice to staff in order for them to perform their desired functions. • Provide Subject Matter Expertise for quality critical components and materials. • Evaluate practices for compliance and operational excellence improvement on a continuous basis. • Manage inspection outcomes, including inspection response compilation and tracking. • Support of Equipment Qualification/Validation activities including protocol creation/report review. Basic Qualifications. • University degree gained in Chemistry, Biology or Science related discipline. • Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role. Preferred Qualifications. • Excellent written and verbal communication skills. • Proficient in the use of systems; SAP, QMTS, Efinity, EDMQ and SM-LIMS, Maximo. • Experience working with raw material suppliers. • Understanding/experience with NC/CAPA system, Change Control Management System, and Documentation Systems. • Knowledge of applicable Regulatory requirements & Standards. • Experience with Regulatory inspections desirable. • Operational Excellence experience desirable. • Experience utilizing Lean principles and a risk-based approach desirable. • Experience working with teams and influencing decisions. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2131 days ago