Establishes, implements and maintains ISO/IEC 17025 management system and WHO good practices in pharmaceutical quality control laboratory. Coordinates with the accreditation body for obtaining ISO/IEC 17025 accreditation. Obtains import licenses for pharmaceutical products for testing and analysis. Supervises and assigns staff with testing activities, documentation and training for laboratory policies and procedures (SOPs). Performs method validation and verification. Prepares reports including management review, internal audit and other necessary reports to Laboratory Management team.
- Establishes, implements and maintains ISO/IEC 17025 management system and WHO good practices in pharmaceutical quality control laboratory
- Coordinates with the accreditation body for obtaining ISO/IEC 17025 accreditation
- Coordinates with Thai FDA for obtaining import licenses and arranging importation of pharmaceutical products for testing analysis
- Performs method validation and verification
- Ensures method validation and method verification reports are correct
- Maintains, calibrates and operates analytical instrument
- Troubleshoots new methods and analytical instrument
- Implements risk management, data integrity and computerized system validation under risk based approach to the laboratory according to WHO Guidance of Validation of Computerized System
- Manages complaint and non-conformity to ensure that the cause(s) of the non-conformity is eliminated and proper CAPAs are effectively conducted
- Supervises and assigns staff with test activities, documentation and training for laboratory policies and procedures (SOPs)
- Prepares reports including management review, internal audit and other necessary reports to Laboratory Management team
- Reviews laboratory results, technical documents and records
- Summarizes pharmaceutical laboratory analysis and periodically report to Laboratory Management team
- Responsible for Safety Health Environment (SHE) and other safety programs
- Performs other duties as assigned.
- Strong knowledge of ISO/IEC 17025 management system, WHO good practices for pharmaceutical quality control laboratory required
- Supervisory or management experience required
- Good Command of English and Thai
- Self-motivated, result-oriented
- Excellent interpersonal and communication skills
- Ability to work under pressure
- Competent usage of computer programs such as MS Word, Excel, etc.
PROBLEM SOLVING & IMPACTS:
- Works on problems of moderate scope that require analysis of data or identifiable factors
- Exercises judgment within defined policies and procedures to determine appropriate actions
- Decisions made generally affect delays in schedules and failure to achieve goals of the department
SUPERVISION GIVEN/RECEIVED:
- Supervises staff to meet departmental and organizational goals
- Assists with management decisions and activities
- 5-8 years of experience working in ISO/IEC 17025 accredited laboratory, ISO 9001 certified organization or equivalent
TYPE AND NATURE OF CONTACTS:
- Routine coordination with FHI 360 employees and consultants, on-site and in the field and resolve problem situations with tact.
- Represent, as assigned, selected LINKAGES Thailand activities and other organizations including donors, and international and local partners.
- Interact with implementing partners, and FHI 360 colleagues working on LINAKGES Thailand.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.