Cache of job #14042022

Job Title

Senior Quality Assurance Specialist

Employer

ICDS Recruitment

Location

Dublin North

Description

Senior Quality Assurance Specialist. Key Purpose: The ideal candidate will work with Quality Assurance Manager, and staff to foster an ethos and culture of cGMP & Quality awareness, where the cGMP’s and Quality are an integral part of the overall business. Always ensureing that plant and processes are run in compliance to current Good Manufacturing Practices (cGMP), including data integrity. The candidate will provide effective real time support for manufacturing operations including QC in batch record review, deviation and incident management, CAPA development, change management, complaint investigations, cleaning activities and purified & process water system support. Key Responsibilities: Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution. Support audit program including Internal and external auditing and regulatory/ customer inspections. Compilation and review of QA SOPs. Support warehouse operations including finished product labeling / shipping checks, and temperature mapping activities to ensure compliance with. Good Distribution Practice, Support program for outsourced service providers. Review & approval of plant, warehouse and QC procedures. Providing quality input and support the resolution of technically complex issues within manufacturing operations in compliance with cGMP requirements, ensuring decisions made maintain product quality. Review and approval of relevant protocols, as appropriate. Involvement in site-wide projects and support operational excellence initiatives. Support Key User activities for QA systems (including LMS and TrackWise. Ensure compliance with relevant regulations and standards associated with ISO 14001, EMAS, Health & Safety Legislation, Environmental Legislation, and also all site standards, policies, and procedures. Other issues as directed by the Manager, Quality Assurance. Qualifications / Education Required: Third level qualification in Science or Engineering discipline preferably with 5 to 7 years experience of working in a GMP environment. Knowledge of regulatory requirements related to pharmaceutical manufacture. Able to work effectively using own initiative and have good organizational skills. Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels. Efficient in document management systems and TrackWise desirable, or other quality management systems. This job originally appeared on RecruitIreland.com.

Date Added

1718 days ago

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