The
U.S. Pharmacopeial Convention (USP) Senior
Scientist I, Master’s Degree in Chemistry
(Analytical/Organic) or Pharmaceutical Sciences
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.
This
is a non-supervisory position in in the Compendial Development Laboratory (CDL)
within Global Laboratory Operations. The incumbent will be responsible for
performing USP/NF/FCC method development and method validation projects and
maintaining safety and GLP environment in the lab. This position is a component
of USP’s core business and the incumbent is expected to support monograph
modernization initiatives.
Roles
and Responsibilities
Coordinate
with supervisor to ensure GLP and safety compliance in the lab.
Search
literature for the USP/NF/OTC/DSC/FCC/Excipient projects.
Ensure
availability of projects requirements in coordination with the Group Leader.
Execute
project involving method development and validation of USP/NF/DSC/FCC/OTC
projects.
Coordinate
with Group Leader to complete the USP/NF/DSC/FCC/OTC projects within timelines.
Assist
Group Leader as deputy for preparations of project reports and compilation of
data.
Provide
training to the new joiner about USP/NF/DSC/FCC/OTC projects and provide
support to junior staff.
Review
project plans, reports, Laboratory notebook/ Electronic laboratory notebook and
compile related project data.
Monitor
projects steps such as inward, under process, archival, disposal, etc.
Mentor
the team members to resolve technical challenges and criticalities.
Ensure
that the calibrations of the equipment are performed as per the schedule.
Prepare
and review of relevant SOPs.
Support
and co-ordinate for completion of IQ/OQ/PQ for new instruments.
Provide
hands-on training to the new joiners and existing scientists.
Plan
and coordinate with Group leader for internal audits, ISO-9001, ISO17025 audits
and related activities.
Provide
support to Group leader for responding to QA observations on time.
Required
Skills
Master’s
Degree in Chemistry (Analytical/Organic) or Pharmaceutical Sciences with 7-10
years of experience. Exceptional breadth of pharmaceutical industry experience.
Excellent technical writing and oral communication skills required. Must be
able to communicate effectively with diplomacy and enthusiasm. Technical and
analytical skills required including the ability to interpret technical
information. Must have hands on experience in working with chemical methods and
handling instruments like HPLC, UHPLC, LC-MS, GC, GC-MS, IC, ICP-OES/MS, FTIR,
UV-Visible. Should have good understanding of GLP regulations and exposed to
external regulatory audits.
TO APPLY CLICK HERE
FOR MORE JOB UPDATES
No comments:
Post a Comment