- Serve as Quality Assurance SME for quality control activities maintaining knowledge of industry standards and regulatory requirements to ensure all quality control activities are compliant.
- Active member of the QA Operations team ensuring on-time disposition of finished product. This should be achieved through completion of the following activities:
- Review and assess QC deviations; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
- Review and assess QC Laboratory Investigations
- Review and approve QC generated Corrective and Preventive Actions (CAPA); including tracking, follow-up, and reporting/trending and evaluating CAPAs for effectiveness.
- Provide Quality support to QC department in method transfer or validation activities.
- Support the work of the Quality Systems and Compliance team by the coordination and optimization of Quality Management Records relating to Deviation, Change controls and CAPA.
- Support Global Complaints Handling Unit (GCHU) in complaint investigations.
- Supports the business through coordination of day to day operations and change management relating to Quality e-Systems such as TrackWise
- Generation, development and communication of Site Quality Metrics and measurements to support the on-going development of site compliance.
- May create or revise standard operating procedures relating to various quality system elements
- Represents Quality Assurance to guide various projects and technical meetings, as needed
- Responsible for documenting and reporting compliance issues to management.
- Minimum of B.S. degree in Chemistry, Biology or related field
- Minimum 3 years of experience in QA and/or QC
- Thorough knowledge of cGMP/GLP/GDP and international regulatory requirements.
- Demonstrated ability to coordinate and drive improvement in processes supporting Quality Systems or Quality Control.
- Proven ability to identify, influence and drive process improvement.
- English fluency written and spoken (the Company language).
- Efficient in SAP, firstdoc. and Trackwise® would be an advantage.
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