Your Responsibilities : Job Purpose
Ensure Quality Compliance of Products / Materials at various stages of testing (including raw material, intermediate and finished product & stability testing) to fulfill regulatory and GMP / GLP requirements, coordinate for the fulfillment of GMP compliance and various quality requirements as per GQMPs and GQPs and manage the product validation program in line with GMP requirements.
1)Managing the stability program at site through preparation of annual schedule, tracking the monthly testing status of stability samples.
2)Coordinate with different functions like OQ, Production and planning for timely collection of the samples as per annual schedule.
3)Timely placement and withdrawal of sample from stability chambers and making sure these are included with the routine testing.
4)Keep the stability chambers updated and in ready status by monitoring the data as per defined frequency.
5)Receiving of representative samples of raw materials, finished and intermediate products for timely releases by Lab. Operations.
6)Release of Raw Materials and / or Intermediate Products in LIMS & BPCS (if assigned).
7)Analysis of stability and / or validation samples and interpretation of results.
8)Follow GMP and safety requirements of laboratory.
9)Participate in the testing of new products and product development.
10)Participate in various EHS activities.
11)Conduct and participate in JFT / GMP training sessions.
12)Support in preparation and revision of existing SOPs, Testing Standards and Test Methods to set standards as per GMP compliance.
13)Demonstrate proficiency in standard computer software.
14)Handle special / additional assignments given from time to time to fulfill local as well as corporate requirements.Basic qualifications :
Preferred qualifications :
Why GSK? :
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-
leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy.
To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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