PpbMetrology Supervisor /b /p /p p(m/f/d) /p Freelance/temporary employment for a project Lengnau, Berne Start date: asap Reference number: /1 ppb Diesen Job teilen oder drucken /b /p /p ppb Responsibilities /b /p /p liLead and oversee daily metrology and calibration activities across GMP areas (manufacturing, QC, labs, utilities) /liliEnsure all measuring and test equipment is calibrated and maintained in compliance with GMP, FDA, EMA, and ISO standards /liliManage the full calibration lifecycle: planning, execution, review, approval, and documentation /liliReview and approve calibration certificates, OOT results, deviations, and technical assessments /liliDrive and manage deviation, CAPA, and change control processes related to metrology /liliEnsure data integrity according to ALCOA+ principles in all records and electronic systems /liliSupport internal/external audits and regulatory inspections, ensuring inspection readiness /liliCollaborate with QA, Engineering, Validation, and Manufacturing on equipment qualification (IQ/OQ/PQ) /liliMonitor and report KPIs (compliance, turnaround time, right-first-time performance) /liliTrain, mentor, and develop metrology technicians in GMP and technical competencies /li ppb Profile /b /p /p liBachelor’s degree in Engineering, Life Sciences, or a related technical field /liliExperience in metrology/calibration within a GMP-regulated pharma/biotech environment /liliProven leadership or supervisory experience /liliStrong knowledge of GMP regulations (21 CFR 210/211, Annex 11) and regulatory expectations /liliSolid understanding of measurement uncertainty, risk-based calibration, and critical instrumentation /liliExperience with computerized system validation (CSV) and ALCOA+ data integrity requirements /liliFamiliarity with QMS processes, including deviations, CAPA, and change control /liliStrong analytical and problem-solving skills with a structured, quality-driven mindset /liliExcellent communication and cross-functional collaboration skills /liliContinuous improvement mindset with experience in process optimization /li ppb Benefits /b /p /p liRenowned pharmaceutical company /liliAttractive salary package /liliHAYS Benefits /li