SENIOR ASSOCIATE
- Malaysia
- Permanent
- Full-time
- Review and Approval of Deviation, Out of Specifications, and Out of Trend investigations.
- Reviewing SOP of other departments especially Quality Control.
- Participating Peer Review Meeting for Quality Assurance and Quality Control (Analytical and Microbiological) documents.
- Coordinating meeting for related cross functional teams related to Peer Review.
- SOP preparation for Quality Assurance - QC
- Training of cross-functional teams on Quality Assurance procedures.
- Review of Change Management, and CAPA, CAPA EM
- Familiarisation of Quality Control (Analytical and Microbiological) function and activities.
- Support to provide Quality Control data for regulatory filings as per requirement
- Performing cGMP inspections including preparation of reports and follow-up CAPA.
- Training of Quality Assurance procedures to cross-functional teams.
- Ensure adherence of compliance at Quality Assurance area (office and archival area) and to notify any non-conformities.
- Any other assignment given by reporting manager
- Review and Approval of Deviation, Out of Specifications, and Out of Trend investigations.
- Reviewing SOP of other departments especially Quality Control.
- Participating Peer Review Meeting for Quality Assurance and Quality Control (Analytical and Microbiological) documents.
- Coordinating meeting for related cross functional teams related to Peer Review.
- SOP preparation for Quality Assurance - QC
- Training of cross-functional teams on Quality Assurance procedures.
- Review of Change Management, and CAPA, CAPA EM
- Familiarisation of Quality Control (Analytical and Microbiological) function and activities.
- Support to provide Quality Control data for regulatory filings as per requirement
- Performing cGMP inspections including preparation of reports and follow-up CAPA.
- Training of Quality Assurance procedures to cross-functional teams.
- Ensure adherence of compliance at Quality Assurance area (office and archival area) and to notify any non-conformities.
- Any other assignment given by reporting manager
Required Experience: 4 - 6 years