Qa/Qc Manager

17 hours ago

Limerick, Limerick, Ireland Fohntech Group Full time

Job DescriptionWe are seeking an experienced Mechanical QA/QC Manager to lead and oversee all quality assurance and control activities on mechanical systems within large-scale pharmaceutical and construction projects.The successful candidate will ensure compliance with industry standards, project specifications, regulatory requirements (GMP, ISO, etc.), and company quality procedures.Key Responsibilities:Develop, implement, and maintain project-specific QA/QC plans and procedures for mechanical systems (HVAC, piping, utilities, etc.).
Oversee all mechanical QA/QC processes, including material inspection, installation, testing, and commissioning.Conduct quality audits and inspections to ensure compliance with project specifications, GMP, and regulatory standards.Manage QA/QC documentation including inspection test plans (ITPs), method statements, checklists, NCRs, and punch lists.Liaise with project managers, engineering teams, clients, and third-party inspectors to resolve quality-related issues.Review and approve subcontractor quality submissions and verify adherence to contract quality requirements.Lead the mechanical handover and turnover process, ensuring all quality documentation is in place.Train and supervise QA/QC engineers and inspectors assigned to the mechanical discipline.Coordinate with cross-functional teams to support continuous improvement initiatives and ensure lessons learned are applied to future projects.Required Qualifications & Experience:Bachelor's degree in Mechanical Engineering or related field.Minimum 8 years of QA/QC experience in mechanical systems within the pharmaceutical and/or construction industry.Strong knowledge of GMP, ISO 9001, ASME, ASTM, and other relevant mechanical and quality standards.Proven experience in cleanroom environments, HVAC validation, utility systems (WFI, PW, HVAC, process gases), and pharmaceutical mechanical installations.Familiarity with commissioning, qualification (IQ, OQ, PQ), and validation protocols.Experience with QA/QC documentation, inspection reporting, and turnover packages.Excellent organizational, communication, and leadership skills.Proficient in MS Office, QA software/tools, and documentation platforms.Next StepsIf you are interested in this role, please apply directly or email your CV to ******/ QC Manager / Lead

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