To perform timely analysis and ensure release of raw materials / finished products / stability testing of products and raw materials ,validations of sterile processes, products, equipments, cleaning validations, environmental and water systems monitoring in compliance with applicable QMS & Regulatory requirements.

Responsibilities

• Perform microbiological analysis of Finished products, stability & raw material testing to ensure the microbiological quality of ampoule and Eye Drop products / Cephalosporin products through compliance with the set standards of DI and QMS and ensuring proper documentation.
• Preparation of media in ampoule and Eye Drop / Cephalosporin lab and performance of Growth Promotion test; culture maintenance and inventory control in ampoule and Eye Drop / Cephalosporin lab.
• Perform Viable and Non-viable monitoring of Sterile Ampoule and Eye Drop / Cephalosporin / tablet and suspension production areas trending of area monitoring (Sterile, Non-sterile) and summary reporting.
• Sampling testing and reporting of Raw material, pure steam and Water System of ampoule and Eye Drop / Cephalosporin areas prepare summary report of water and environmental monitoring.
• Perform Microbial Limit Test, Bacterial Endotoxin, Bioburden and sterility test of Raw materials, packaging components and finished products of ampoule and Eye Drop products / Cephalosporin.
• Perform Bioassay of multivitamins and antibiotics and support in stability studies and product validations in ampoule and Eye Drop products / Cephalosporin tablet and suspension areas.
• Analytical method validation testing (as per requirement) and perform all activities of testing related with current SOP versions of ampoule and Eye Drop / Cephalosporin products.
• Ensure proper documentation and logging of results of ampoule and Eye Drop and Cephalosporin area and prepare reports to comply with data integrity requirements, perform assigned actions and ensure timely completion and closure of VQMS actions.
• Provide support in development of new SOPs, review of existing SOPs and their implementation; provide support to maintain the GPS in ampoule and Eye Drop products / Cephalosporin labs; audit preparation and audit readiness in both microbiology labs.
• Lead microbial investigations, root cause analysis and CAPA implementation; lead method validation and cross-functional projects, act as microbiology SME during audits and regulatory interactions, drive continuous improvement, lead CI projects to closure and maintain microbiology KPIs or any other responsibility assigned from time to time as per business requirements.

Education, Experience and Skills

• BS. Microbiology / BS. Biotechnology or Equivalent is required for this role.
• Minimum 1 - 2 years of relevant experience is required.
• Use of MS Office ( Word ,Excel ,Power point ) at least to a moderate level .
• Good communication and presentation skills.
• Expertise in sterile area EM, Bioassay testing, Microbial Limit test and all other testing of microbiology.

Skills

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

Contact information:
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