Organization : FHI 360
Type : Nonprofits / องค์กรไม่แสวงหาผลกำไร
Date : 6 Feb 2019
View : 683
Deadline : 8 / March / 2019
POSITION TITLE: Manager, Pharmaceutical Laboratory
REPORTS TO: Associate Director, Research, PQC Chemical Lab
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.
APPLIED KNOWLEDGE & SKILLS:
- 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
- Supervises staff to meet departmental and organizational goals
- Assists with management decisions and activities
- Bachelor’s degree in Pharmacy, Chemistry or related field
- 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.
WORKING CONDITIONS AND PHYSICAL REQUIREMENTS:
- Typical office and laboratoryenvironment
- Ability to lift 5-50 lbs
- Travel domestically at least 10%
1.BS/BA or MS/MA in public health or related field, and 3 - 5 years relevant experience with international development programs and field experience especially in the field of SBCC and/or HIV/AIDS.
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
If you are interested in this position please send your cv directly to firstname.lastname@example.org
Contact : email@example.com / Tel: 02 2635273