Job Purpose
To perform timely analysis and ensure release of raw materials and finished products and to conduct stability studies of products and validations of sterile processes, products, equipments, cleaning validations, environmental and water systems monitoring in compliance with applicable QMS & Regulatory requirements.
Education, Experience & Skills
BS. Biology/ BS. Microbiology
1-2 years prior experience
Computer literacy, minimum to access and utilize emails for official correspondence.
Use of MS-Office (Word, Excel, PowerPoint ) at least to a moderate level.
Good communication and presentation skills.
Expertise in sterile area EM, Bioassay testing, Microbial Limit test
Key Responsibilities
Perform microbiological analysis of Finished products, stability & raw material testing to ensure the microbiological quality of ampoule and Eye Drop products through compliance with the set standards and ensuring proper documentation
Preparation of media and performance of Growth Promotion test.
Perform Viable and Non-viable monitoring of Sterile Ampoule and Eye Drop production processes.
Support in stability studies and product validations.
Analytical method validation testing as per plan provided (as per requirement).
Perform Microbial Limit Test and Bacterial Endotoxin test of Raw materials, packaging components and finished products.
Sampling and testing of Raw material, pure steam and Water System.
Perform the Bioassay of multivitamins and antibiotics.
Culture maintenance and inventory control.
Trending of area monitoring Sterile, Non-sterile and water systems and summary report of water system.
Perform assigned action and there closure at QWF/VQMS.
Ensure proper documentation and logging of results and prepare reports to comply data integrity requirements.
Provide support in development of new Sops, review of existing SOPs and their implementation.
Provide support in GPS.
Audit preparation and audit readiness.
Perform all activities of testing related with current SOP versions. Any other responsibility assigned from time to time as per business requirements
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
Contact information:
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