SYNGENE Career Opportunities: Executive Quality Control M. Pharmacy or M.Sc. (Analytical Chemistry/Organic Chemistry) Apply Now
Job
Description:
Responsible
for performing the physicochemical and instrumental analysis and investigations
(Drug substance, Drug Product, Intermediate and Excipient) for stability
testing lab.
Responsible
for performing analytical method validation and analytical method transfer.
Deliver
results ‘Right First Time’ and within the established windows.
Participation
in internal, client and regulatory audits.
Compliance
with quality systems in laboratory.
Ensure and
comply with GMP, GDP, Data Integrity EHS policies laid down by the
organization.
Flexibility
to work in any project/team as per the requirement.
Preparation
of documents like stability summary reports, stability protocols, SOP.
Responsible
for audit readiness.
Performance
of instrument calibration, qualification whenever required.
Key Responsibilities:
First pass
analysis of stability samples i.e. drug substances and drug products.
Ontime
escalation of laboratory issues.
Initiation of
QMS records on time.
Educational Qualification:
M. Pharmacy
or
M.Sc.
(Analytical Chemistry/Organic Chemistry)
Technical/functional
Skills:
2.5 to 3
years of working experience in Stability and Quality control.
Candidate
should have experience in analysis of drug substance and drug products.
Good
analytical skill and shall perform analysis right first time.
Hand on
experience of HPLC, GC, KF coulometer, KF titrator, Dissolution tester and IR.
(experience in PXRD, DSC, Particle size analysis, LCMS is preferred.
Experience in Chromeleon software, LIMS,
Trackwise will be added advantage.
Good understanding of GMP, GDP and data
integrity principles.
Quick learner
and early change adaptor.
Experience in
regulatory audits is must.
Experience:
2.5 to 3
years of working experience in Stability and Quality control. (Drug substances
and drug products)
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