“ Within days of signing up with Jobsbac, I managed to secure a job with my dream company. I couldn’t believe it was that fast! ”
Develops and revises standardized policies and procedures to ensure laboratory compliance
Manages and conducts internal laboratory compliance investigations for FP/IP/STABILITY/AMV&AMT functions. Develops and adheres to a laboratory compliance program specifications.
Ensure Good Documentation Practise (GDP) is in place and applied in recording of QCA daily activities for easy traceability and facilitate audit requirement.
Serves as the resource for all compliance questions from the lab.
Assist in preparation and continuous improvement of all relevant SOPs, EOPs, Specifications and ensure those procedures are revised and updated in accordance to stipulated interval and as per cGMP requirement/latest pharmacopoeia.
Oversees laboratory compliance self-assessments, coordinates laboratory audits, and identifies compliance risks and issues. Benchmarks and shares best compliance practices in the laboratory area.
To support in identifying the resources
Coordinating with the PMO and SCM teams on month wise planning within QCA for various projects which involves RM, IP, FP, Analytical Support and Stability teams.
Involve in Operational Excellence and Compliance Initiatives, setting and monitoring metrics of performance and KPI’s of the various teams in QCA.
Coordination with QCA teams internally on the planning and prioritization for testing and approval status for Finished Product (DS and DP).
Coordinate with Finance and management teams for budgeting, track and maintain expenses against defined budget for QCA department.
Handling of Lab Incident investigation and ensuring proper closure of the lab incident.
Handling of Product Complaint and assist in the investigation and coordination with QA.
Handling OOS investigation through liaison with analyst and immediate superior.
Coordinate with IT team and user for Computerized System Validation on all the analytical equipment in QCA department in line with Corporate IT SOP requirement.
Facilitate Audit and involve in corresponding the audit response.
Responsible for preparation for any revision and new of relevant document and issuance of change control management form and deviation.
Responsible for approval of purchase request of chemicals, standards, reagents, analytical columns, stationaries and consumable item belongs to Quality Control Analytical Department.
Train and assist QCA personnel on activities related to procurement of standards and consumables through SAP system.
Train on the SOP and other document to QCA personnel.
Trending of Analytical data
Field of Study
Kindly contact Ms Angeline Wong for further details at 07-2305453 ext 20 / or forward your resume to [email@example.com]