Responsibilities
- Handling of Incidents, OOS, OOT, OOC, deviations and change control in Quality Control Department
- Implementation of CAPA related to QMS to all Quality Control laboratory
- To provide training related to QMS to all QC personals
- Preparation of trends data for OOS, OOT and incidents in Quality Control
- To prepare and review investigation of QC and other departments as CFT member
- To ensure all analysts are trained and qualified in required analytical test methods/techniques
- To ensure submission of stability data to QA/RA for registration of drug products to different regulatory bodies
- To prepare and review SOPs, STPs, Specifications , GTP and Protocols of Quality Control Department
- To ensure Internal and External Calibration/ Validation, Temperature Mapping of Instrument and Equipment of Quality Control Department
- Responsible for Preventive Maintenance , Calibration and Qualification of instrument and equipment of Quality Control Department
- To coordinate with outside testing laboratories or inter location laboratories
- Ensure that all analysts understand and follow current good laboratory practices
- To coordinate with external vendor for procurement of QC requirements
- To arrange internal and external training for QC persons to improve knowledge and work efficiency
- Monitoring temperature and relative humidity of stability chambers as per approved procedures
- Responsible for GLP section such as planning and execution of in-house working standards , handling and usage of HPLC/GC columns, chemical management
Requirements
- B. Pharm/M. Pharm, B.Sc./M.Sc . (Chemistry, Industrial Chemistry)
- Minimum 2 years experience in in pharmaceutical field or related working experience
- Good in English both oral and written communication skill
- Familiar with Microsoft packages
- Having good communication and interpersonal skills
- Knowledgeable in Good Laboratory Practices
- Highly motivated and self-initiative personal
- Able to work under pressure and flexible in any situation
Other Information
- Salary: 600,000 ~ 800,000 MMK
- Working Days: Monday to Saturday
- Working Location: Thilawa
If you are interested in this job, please email your resume to apply@achievecareermyanmar.com or call 09970178877 for other information.