Texcell is a Contract Service Organization present in Europe (France & Germany), USA and Asia (Taiwan, Korea & Japan). Texcell has been providing for 30 years’ services to Pharmaceutical and Biotechnology companies, in the field of viral Biosafety testing, GMP Cell banking, Immunology, in vivo toxicology, and in vivo medical devices testing for CE labelling.
To accelerate its development in Asia, Texcell is seeking for Texcell – Asia, its Taiwanese subsidiary,
a GLP Quality Supervisor.
This is a permanent full time Job in Taipei, with frequent travelling to Hsinchu. After an initial training in France to master Texcell’s GLP services, testing processes and QA procedures, the successful candidate will provide on behalf and under the authority of Texcell’s quality manager, a full QA GLP support to audit and certify the compliance to GLPs and initial specifications of the locally subcontracted studies.
• Carries out quality audits of Good Laboratory Practices (GLP) analyzes (protocols, report, technical document, certificates of analysis and raw data)
• Conducts external audits (suppliers and subcontractors) and ensures the follow-up of the CAPA plan
• Participates to sponsors audits and follow-up of CAPA plan
• Ensures a regulatory and normative watch especially at the level of the GLPs.
• Source of proposals for the improvement of the quality system
Within the framework of GLP regulations, and for the studies in which he/she participates:
- Verifies authorization documents
• Verifies qualifications records for equipment and premises
• Verifies validation records of the methods and information systems used
• Verifies and approves study plans
• Verifies raw data and results
• Verifies and approves study reports
• Verifies the archiving of study files
• Issues on behalf of Texcell the reports of conformity of the results to the initial specifications and GLP standards
• Follows CAPA actionsMain Responsibilities:
• Is responsible for the consistency of the proposed study plans against the recommendations of the regulatory authorities (ICH, TFDA, CFDA, KFDA, PMDA, EMA, FDA, ANSM, …) and / or national or international standards EN, ISO) in the field of competence of the laboratory
• Is responsible for documents, plans, study reports signed by him / her
• Is responsible for signed compliance reports
Internal & external responsibilities:
Maintains a permanent relationship with all technical staff and quality of the subcontracting partner.
Answers to the requests of the sales department to prepare quotations
Reports to the Quality Manager on discrepancies and malfunctions in the scope of his / her duties
Is the local interlocutor of the regulatory authoritiesMay be required to present the study report to the client and / or health authorities
Essential skills for this function:
Master Degree or Ph.D. in Biological Science / Pharmacy or related discipline
Minimum 2 years in a Quality / production position
Languages: Chinese (Mandarin) and English read, written, spoken
Realization of field quality and documentary audits
Experience of Good Laboratory Practices
Good communication skills with ability to collaborate with other functions
Rigorous and self-motivated professional
Please adress your Resume/Cover Letter to : firstname.lastname@example.org