The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Post : Specialist, Laboratory Quality Management Services
Job Description
This is a hands-on, non-supervisory position which is primary responsible for providing technical assistance in such areas as laboratory equipment evaluations and training, selecting approved ILAC accreditation bodies, conducting ISO/IEC 17025:2005 Section 4 and Section 5 Training, WHO- prequalification preparation and follow-up evaluations and generating documents for standardization as needed. The position supports the Global Health Impact Program department under the Promoting the Quality of Medicines (PQM) program. In addition, the incumbent designs, develops and implements new tools and techniques used in the overall Quality Systems with the technical assistance support of PQM.
Roles and Responsibilities
- Provides technical assistance for ISO 17025 accreditation and WHO pre-qualification by assessing, auditing, preparing and reviewing documents, and providing necessary training for onsite staff.
- Conducts facility inspections to ensure environmental, equipment and staffing capabilities, which will be applied to corrective and preventive actions
- Participates in all Quality Management Systems training, focusing on investigations, corrective and preventive Actions (CAPAs), Proficiency Testing, and Internal Auditing in order to evaluate and trend the laboratory’s progress toward ISO 17025 accreditation or WHO prequalification.
- Tracks and trends data to support quality metric reports ensuring laboratory compliance and follow-up through continual improvement.
- Performs other related duties as required or assigned.
Required Skills
- Knowledge of analytical chemistry and QA/QC processes in the pharmaceutical industry required.
- Advanced understanding of ISO 15189,17025, 17043, 9001, and Guide 34 and general understanding of cGMPs.
- Microbiological background is preferred and familiarity with QA/QC of pharmaceuticals is a must.
- Exposure to the concept of “Measurement Uncertainty” within relevant laboratory areas.
- Well-developed meeting facilitation skills.
- Demonstrated skill in audit planning and lead auditing techniques.
- Previous Certified Quality Auditor CQA (spell out) or lead auditor training is preferred
- Demonstrated strong public speaking skills related to managerial and analytical activities.
- Solid skills in MS Word, MS Projects, Excel, and PowerPoint.
- Ability to explain complex information in simplistic terms, to a diverse audience.
- Ability to travel at least 50% of the time to international locations.
Find More Info Go Next Page...
Subscribe to Pharmatutor Job Alerts by Email
Required Experience
Masters in Science or pharmacy with relevant quality assurance experience in a pharmaceutical, biotech, or other regulated industry.
Minimum of six years’ experience of which at least three years in QA/ auditing QC labs and 3 years’ experience in hands on laboratory testing
Additional Information:
Experience: 6 years
Qualification : M.Pharm, M.Sc
Tracking Code: 951-679
Location: Hyderabad, Andhra Pradesh, India
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: R&D
End Date: 30th September, 2017
See All USP Alerts Ph.D Alerts M.Pharm Alerts M.Sc Alerts
See All Other Jobs in our Database
.png)
