مدیر آزمایشگاه کنترل کیفیت

Job Description

-Demonstrate strong leadership and management skills, communicate effectively, manage multiple workloads and coordinate all QC activities with the Senior Quality Manager -Work closely with all departments including the commercial and logistics departments to help understand customer requirements and plan the timely testing and release of product batches and assist with the review of all QC analytical data and ensure that right first Time KPIs are achieved -Install a KPI system -Manage and schedule routine and annual maintenance, troubleshooting and of all analytical equipment and analytical practices and procedures in order to uphold continuous improvement -Manage Analyst work schedules and ensure that planned work is effectively communicated and adhered to -Manage Analyst timesheets, holiday and coordinate all laboratory events and manage laboratory audits and findings -Manage Analyst training curriculum and maintain and update all laboratory and analytical documentations -Manage and maintain all laboratory software -Troubleshoot all QC analytical methods, equipment and calibrations. -Support continuous improvement in the laboratory and identify gaps in the current QC processes and plan improvement/ implementation with the QC Manager -Act as a primary contact for laboratory related queries and liaise extensively with internal and external customers -Ensure all testing and associated activities are performed in accordance with GMP and strict industry compliance standards -Manage the QC laboratory waste program and ensure that all QC generated waste are properly segregated and disposed -Manage all laboratory OOS, OOT, deviations and change controls and liaise with QA -Be responsible for equipment qualification, calibration and maintenance -Be responsible for all method validations -Be responsible for Technical Agreements related to the department -Be responsible for the stability studies program of the company -Be familiar with Eudralex Vol IV and other related directives and regulations especially those related to QC work -Sampling plans and retained sample management -Chemical, microbiological, biological, and physical testing/ batch analysis -Out of Specification (OOS) result investigations and trending -Specification approval -Release of raw materials, packaging components, in process materials -Approval of in-process controls -Calibration verification of QC equipment -Management of reference standards -Qualification of QC equipment -Stability program, controls and testing -Complaint analysis -Testing of validation samples -Contribution to raw material supplier approval -Assistance in audits of contract labs -Quality Agreement evaluation -Annual Product Review (APR) data compilation -Pharmacopoeia reviews -Supplier testing approval -Statistical Process Control (SPC) / Statistical Quality Control (SQC) -Environmental monitoring 40. Global specification standardization 41. Analytical Development either as part of QC or separate organizational unit (e.g. method development, method validation, specification generation, method transfer, new QC technologies Pharmacopoeia review, troubleshooting) -Participate in analytical method transfers -Participate in supplier or vendor audits, qualification related to QC activities -Authorization of written procedures and other documents, including amendments related to QC testing -QC premises hygiene -Retention of relevant records -Monitoring of compliance with the requirements of Good Manufacturing Practice in the QC department -Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management -Any other duties assigned by the Quality Senior Manager related to the pharmaceutical industry -Reporting to: Senior Manager for Quality *Shift and 'on-call' work may be required, particularly where manufacturing/production equipment is in continual 24-hour operation