Preclinical Quality Specialist (Pharmaceutical/ Lab)
Our client is a Leading Tobacco company in Singapore. We are currently looking for a Preclinical Quality Specialist to support the operations
- 12-Month Contract (Renewable)
- Location: Central
- 5 Days Work
- Up to $3900 depending on experience
- Responsible for applying a local Quality Assurance program for Good Laboratory Practices for non-clinical studies to assure corporate management that the facilities, equipment, personnel, methods, practices, records and controls for each non-clinical laboratory study are in conformance with Good Laboratory Practice regulations.
- Responsibility for the delivery of robust GLP compliance training.
- Support to monitor that activities are conducted according to local and global Quality Management System.
- Identify opportunities for quality and process improvements in non-clinical development.
- Supports the Quality Assurance Team to ensure that non-clinical laboratory studies are monitored throughout their conduct for compliance with GLP regulations.
- Responsible to ensure that all non-clinical studies outside the scope of GLP are conducted and reported in accordance with the QMS principles, including assessment of Scientific quality excellence.
- Perform the Quality Assurance review of new and existing controlled-documents to assess their clarity and compliance with GLP are maintained. These controlled-documents include the standard operating procedures, work instructions and forms.
- "Supports the assessment that the study plan contains the information required for compliance with the GLP Practices and that the verification has been documented.
- Support to verify quality of studies against OECD Principles of GLP from the verification of study plans to inspection of final study reports.
- Participates in the inspection of final reports to verify that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies."
- Perform QA inspections on study-based, process-based and facility-based QA inspections and identified suppliers in accordance to relevant guidelines and scientific standards (e.g AVA, AAALAC, etc), as well as internal QMS.
- Monitor and follow up that the corrective actions recommended are implemented internally or by the external parties.
- Inspections are to be promptly reported to management and the study director.
- Continue to be developed into an expert in understanding of GLP compliance on a global basis including local compliance enforcement experience with Health Authorities.
- Perform the Quality Assurance review of validation of all computerized systems and equipment used for GLP studies and ensure GLP compliance of documents generated in this context and equipments are suitable for their intended purposes.
- Support regular training on the Quality Management System and GLP awareness for new and existing staff.
- Supports the management of the facility's incident (CAPA) reporting programme. This includes the evaluation of incident reports and necessary follow-ups to ensure that each incident is adequately addressed and archived.
- Bachelor's degree in scientific discipline is ideal, with at least 1 years related experience in a pharmaceutical/biologics/biotechnology company;
- At least 1 year working experience in a laboratory environment (chemical/biological analyses) and participation in quality assurance related activities in tobacco, food, pharmaceutical or similar industry and/or at least 1 year experience as a specialist in a relevant area of activity.
- Experience in other quality standard as e.g. ISO 17025 would be ideal.
- Working knowledge of OECD principles of Good Laboratory Practice, knowledge of other quality systems such as FDA GLP Principles, cGMP, ISO, GCP and AAALAC is ideal.
If you possess above relevant skillsets, please send in your updated CV in word format to Apple.firstname.lastname@example.org
Lim Pey Chyi
Recruitment Consultant (R2090579)
Manpower Staffing Services (S) Pte Ltd
EA Licence: 02C3423
Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579