Our client, A Hong Kong pharmaceutical company, need a QC manager based in Hongkong
QC Manager Job
-Supervise and direct the overall performance and effectiveness of QC Laboratory to ensure QC activities fulfill PIC/S and FDA GMP requirements.
-Prepare and implement QC department annual plan
-Direct, guide and manage QC team to enhance their sensitivity and profession on quality issue
-Plan and execute QC quality activity plan annually
-Responsible for enhancing data integrity compliance of QC department
-Responsible for daily QC laboratory operations and to ensure all operations are in full compliance with applicable SOPs, GMP requirements and safety guidelines.
-Provide effective leadership including setting individual and department objectives, employee evaluations, leading departmental meetings, providing performance feedback, recognizing employee contributions, coaching and developing staff.
-To support and supervise QC responsibilities for the performance of all in-process, finished product, process validation, method validation and stability testing.
-Provide guidance and risk assessment for the resolution of discrepancies, OOS, unexpected results, lab investigations and Corrective and Preventative Actions.
-Oversee all aspects relating to the QC instrumentation program including; purchase, installation, qualification, PM scheduling and trouble shooting.
-In charge of continuous improvement to the lab in regards to instrument and method life cycle management.
-Interact with internal and external colleagues, regulatory agencies and internal auditors.
-Represent QC at operational and cross-functional meetings; prepares and presents information, provides decision making support at meetings and disseminates information back to QC.
-Responsible for evaluating new technologies and requirements and implementing them as needed to stay current with best practices and new regulatory demands.
-Responsible to manage department staff and HR related issues.