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.
Bachelor degree or above in chemistry, biology, microbiology and / or life sciences
Minimum 5 years pharmaceutical experience / laboratory management and / or related pharmaceutical experience.
Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements. Demonstrated auditing and corrective action proficiency.
Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.
Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment.
Knowledge of document management / quality systems
Building relationships with other departments
Statistical Analysis capability