My client is a global leader in the biotechnology industry and now seeks an experienced QA Specialist to help with a transformation project. This will be a fixed 1 year contract with excellent opportunities for internal mobility.
- Provide QA oversight and ensure that medicinal products are manufactured in accordance with global Quality Systems and local site requirements
- Provide QA oversight of investigations and Corrective Action and Preventive Action Management System
- Ensure investigation are appropriately conducted considering robust analysis, documentation of root causes and identifying potential risk to operations and product quality
- Assume responsibility for managing of Commercial Products disposition activities in accordance with procedures, performance measures, and standard lead times.
- Lead in the design and implementation of department and cross-functional initiatives
- Perform routine and non-routine activities, with adequate QA oversight to ensure that appropriate standard operating procedures (SOPs) and compliance standards are adhered to, as follows:
- Support document review and approval in Electronic Document Management System (EDMS)
- Serve as a technical subject matter expert support of departmental functions and during audits
- Interface with appropriate departments to ensure that lot disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
- Manage and support lot disposition activities and resources to ensure adherence to schedule
- Degree in Life Sciences or Engineering discipline or equivalent
- At least 5 years of working experience in QA from a pharmaceutical/biotech plant environment
- Good knowledge of quality systems and QA principles, practices and standards for the pharmaceutical industry
- Ability to interpret and relate Quality standards for implementation and review
- Good interpersonal, oral and written communication skills
- Ability to prioritize, plan and manages deliverables effectively
- Proven ability to work well under pressure
Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).