Support the implementation of digital documentation solutions like electronic logbooks and manage the GMP governance and issuance of paper-bound logbooks on site.
Ensures that all water, environmental monitoring, site utilities and product testing samples are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. Develops a strategy for the site with respect to environmental monitoring and water systems. Perform microbiological risk assessment for all non-sterile products
Be accountable for the achievement of the Sales budget and all Objectives set for the year. Perform actions throughout the year to ensure the achievement of results in terms of sales and other defined KPIs.
Perform manual visual inspection of vials, syringes, or other primary packaging for defects such as particles, cracks, discoloration, and fill volume issues.
Setup, operate and maintain all types of conventional or CNC machines such as Milling, Lathe, Surface Grinding, Shaping, Hobbing, broaching and conventional machines in the cell/process
Lead the review and coordination of architectural drawings, specifications, shop drawings, material submissions, samples, mock-ups, and technical submissions.
Develop, update, and implement project QA/QC plans, inspection checklists, quality procedures, and work instructions in line with ISO 9001, project specs, and industry standards.
Lead the review and coordination of architectural drawings, specifications, shop drawings, material submissions, samples, mock-ups, and technical submissions.
Lead a team of analysts to perform daily laboratory operations including organization of sample for analysis, results verifications, and timely release of reports.