Job Description
Job PurposeTo 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 & SkillsBS. Biology/ BS. MicrobiologyMust have an experience of at least 3 to 5 years on the same (or equivalent) positionComputer 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 skillsKey ResponsibilitiesPerform and verify microbiological analysis of Oral finished product, stability & raw material testing to ensure the microbiological quality of product through compliance with the set standards and ensuring proper documentation of ampoule and Eye Drop / Cephalosporin labEnsure proper documentation and logging of results and prepare reports to comply data integrity requirements in ampoule and Eye Drop / Cephalosporin lab .Provide support in development of new SOPs, review of existing SOPs and their implementation. Support and conduct the Gap analysis of GQMP’s, GQP’s, USP and CAPs related to applicable SOPs. Support in compliance of QMS implementation in both Microbiology Labs .Provide support in GPS and in EHS compliance in ampoule and Eye Drop / Cephalosporin lab .Ensuring DI related representation in both Microbiological labsTo support the department in the maintenance and calibration of equipments present in both microbiology labs and calibration Schedules with respect to AEQMS.Performance and verification environmental monitoring of sterile area to ensure the microbiological control on product through compliance within the set standards and ensuring proper documentation.Ensure the qualification and requalification of microbiological equipment and its documentation both Microbiological labsEnsure supervision of third-party Services.Ensure method validation of testing method, are being used in microlab testing.Ensure process validation related to microbiological aspect at the site.Culture maintenance and inventory control.Trending and summary reports of area monitoring Sterile, Non-sterile and Water systems.Ensure proper documentation and logging of results and prepare reports to comply data integrity requirements.Ensure availability of testing material in Microbiology lab by raising purchase order in SAP system to maintain inventory.Ensure to perform routine “Audit Trail Determination Review” of all the relevant microbiological systems.All microbiological lab responsibilities are assigned to staff as per availability and feasibility to provide support in day-to-day activities as per their rolesWhy 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:You may apply for this position online by selecting the Apply now button.Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
