Quality Control Engineer
Current● Maintains company’s IMS (Integrated Management System) for compliance to 9001 and 14001 standards using knowledge of current industry standards, regulatory requirements and authority expectations regarding CQV.● Maintaining documentation in compliance with Good Manufacturing Practices (GMP). ● Periodically reviewing all documents to ensure they meet current regulatory requirements and reflect the latest operating practices in the pharmaceutical industry.● Provides up to date reports on sites and company departments through auditing and NCRs.● Organizes and meets with various partners in such as LCI, VCR, CIF etc.● Perform Quality Audits weekly, monthly, and yearly as required.● Facilitating continuous improvement initiatives to enhance the effectiveness and efficiency of the Integrated Management System.● Conducting comprehensive risk assessments and defining operational thresholds for mechanical systems and installations.● Organizing, executing, and documenting CQV testing.● QA/ QC document control of HVAC, Piping Systems and P&ID● QA/QC document control of system testing, inspection of systems installations and completion of system test pack & hand over / signoff documents● Providing assistance with BCAR documentation during construction handover phases.● Works closely with QA Manager/site Construction Teams to deliver quality installations at each step of the build process – design, detail, construction, sign off and final line walking.● Attends quality meetings with management and subcontractors and report on quality.● Co-ordinate paperwork in line with welding processes including NDT testing of pipework.● Liaising with main contractor / sub-contractors to co-ordinate inspections and tests and document keeping and uploading for inspection.● Walkdown of the systems/check sheets.● Manage test packs, calibration certs, material certs, check sheets, receipt verification and any test packs documents.
