Job Description
-Demonstrate strong leadership and management skills, communicate effectively, manage
multiple workloads and coordinate all QC activities in the physicochemical laboratory with the QC Manager.
-Participate in development and installation of a KPI system in the physicochemical laboratory assisting to QC Manager
-Manage and schedule routine and annual maintenance, troubleshooting and of all analytical equipment and analytical practices and procedures in order to uphold continuous improvement in the physicochemical laboratory.
-Manage Analyst work schedules and ensure that planned work is effectively communicated and adhered to in the physicochemical laboratory.
-Manage Analyst timesheets, holiday and coordinate all laboratory events and manage laboratory audits and findings in the physicochemical laboratory.
-Manage Analyst training curriculum and maintain and update all laboratory and analytical documentations in the physicochemical laboratory.
-Manage and maintain all laboratory software in the physicochemical laboratory.
-Troubleshoot all QC analytical methods, equipment and calibrations in the physicochemical laboratory.
-Support continuous improvement in the laboratory and identify gaps in the current QC processes related to physicochemical laboratory and plan improvement/ implementation with the QC Manager.
-Ensure all testing and associated activities are performed in accordance with GMP and strict industry compliance standards.
-Manage the QC laboratory waste program in the physicochemical laboratory and ensure that all QC generated waste are properly segregated and disposed.
-Manage all laboratory OOS, OOT, deviations and change controls in the physicochemical laboratory and liaise with QA etc
-Responsible for equipment qualification, calibration and maintenance in the physicochemical laboratory
-Responsible for all method validations in the physicochemical laboratory
-Provide assistance to QC Manager related to Technical Agreements in the scope of QC Laboratory
-Provide support to QC Manager in the scope of realisation of the stability studies program of the company
-Manage sampling plans and retained sample management
-Organize, manage and execute chemical and physical testing/ batch analysis
-Out of Specification (OOS) result investigations and trending
-Participate in approval of in-process controls
-Calibration verification of QC equipment in the physicochemical laboratory
-Responsible for the management of reference standards
-Responsible for the qualification of QC equipment in the physicochemical laboratory
-Participate in complaints analysis
-Organize, manage and execute testing of validation samples in the physicochemical laboratory
-Contribution to raw material supplier approval for physicochemical laboratory
-On request of QC Manager provide Assistance in audits of contract labs
-Participate in Quality Agreement evaluation
-Participate in Annual Product Review (APR) data compilation
-Continually assure Pharmacopoeia reviews related to the physicochemical laboratory
-Participate and manage Statistical Process Control (SPC) / Statistical Quality Control (SQC)
-Participate in the Environmental monitoring
-Participate in the global specification standardization
-On request of the QC Manager, to participate in the Analytical Development either as part of QC or as a separate organizational unit (e.g. method development, method validation, specification generation, method transfer, new QC technologies Pharmacopoeia review, troubleshooting)
-Participate in analytical method transfers in the physicochemical laboratory
-Participate in supplier or vendor audits, qualification related to QC activities in the physicochemical laboratory
-Authorization of written procedures and other documents, including amendments related to QC testing in the physicochemical laboratory
-QC physicochemical laboratory premises hygiene
-Responsible for the retention of relevant records in the physicochemical laboratory
-Responsible for the monitoring of compliance with the requirements of Good Manufacturing Practice in the physicochemical laboratory
-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 QC Manager related to the pharmaceutical industry
