Apotex, Analyst-
Commercial Stability Lab Master’s degree Organic/ In-organic chemistry/ M-Pharm
in pharmaceutical chemistry
Apotex is a
proudly Canadian, global pharmaceutical company that produces high-quality,
affordable medicines (both generic and innovative pharmaceuticals) for patients
around the world. We are the 7th largest generic pharmaceutical company
globally with more than 12,000 employees and estimated sales of approximately
$3 billion. Our fully integrated operation is comprised of four lines of
business: Global Generics; Apobiologix; Global Active Pharmaceutical
Ingredients (API); and ApoPharma (Innovative Products). With our worldwide
manufacturing sites, Apotex can produce up to 24 billion dosages per year. We
produce 300 medicines in 4,000 dosages and formats that are exported to 115
countries. Apotex will spend $2 billion over the next 10 years on research and
development.
Job Summary
The position
entitles the incumbent to possess adequate practical and technical knowledge on
the Quality control techniques and related instruments.
Job Responsibilities
The following
areas shall be in preview of the desired candidate but the roles and
responsibilities shall not be limited to:
To do the
stability testing of laboratory Batches, Pivotal batches, Commercial batches
and other stability samples.
Preparing of
the stability protocols, validation protocols and finished product
specifications and SOPs.
Analysis of
stability samples, working standard qualification, maintenance of working
standards and certified reference standards.
Online
monitoring of stability chambers, photo stability chambers.
Analysis of
Finished products, Raw materials and in process by using calibrated instruments
and conventional methods
Calibrating
instruments like pH meter, Autotitrator, UV, IR, Analytical balance and HPLC.
Analytical
method of cleaning validation by UV-VIS SPECTROPHOTOMETER.
Adhere;
follow and implement the Standard Operating Procedures (SOPs), health and
safety practices/ policies.
Prepare the
work sheets and protocol for the Analytical method of cleaning validation.
Manage change
control deviations and closure of the same.
To
co-ordinate within the groups in the laboratory and give guidance for
troubleshooting related to new as well as existing products.
To provide
the technical support during technology transfer of projects
Job
Requirements
Master’s
degree Organic/ In-organic chemistry/ M-Pharm in pharmaceutical chemistry
Minimum of 3
years of experience in a formulation unit.
Hands on
experience in Analysis of Raw materials, In process and Finished products.
Experience in
the formulation unit is a must.
Adequate
knowledge on regulatory guidelines such as ICH, FDA, EMEA.
Candidate
should be well versed with the GLP and safety practices to be followed in the
quality lab.
Should
possess excellent communication skills and be able to work cohesively as one of
the team members.
The candidate
should be willing to work in shifts.
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