Eshwara Chary Allepally Samboju
Site Manager-esq - External Supply Quality Aseptic Processing Quality Management Microbiology @GSK
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WORK HISTORY
Site Manager-esq - External Supply Quality Aseptic Processing Quality Management Microbiology @GSK
Mumbai, IN
o Lead and co-ordinate site-Sterile facilities including QC Microbiology tasks aimed to ensure the production of high quality and compliant product (Sterility assurance).o Influence and assist site leadership (Line managers) team to deliver forecasted/planned supplies covering across all areas- Laboratories in accordance with GSK values.o Manage site level business performance which includes CTP, Quality, OOS, wastes compliance, EHS and cost dimensions.o Ensures the Quality Operations at Contract Manufacturing Organization/External Partner and operates according to the defined policies and procedures of GSK.o Responsible for media fills/APS at the sites and strategy execution.o Ensure audit actions/CAPA observations (Veeva system) are implemented on time with required resources.o Have Shop floor GEMBA (Quality, EHS, Efficiency, Wastage, and Productivity) on regular intervals and make observations and investigate OOS/OOT/Deviations and inform the appropriate team member.o Identifying training needs and ensure training is provided as required to all team members to address skill gaps.o To ensure implementation of GSK QMS requirements at contract sites and to ensure that product is getting manufactured at the site as per cGMP requirements.o To provide support in the area of regulatory compliance at contract sites and to ensure no disruption of supply and no regulatory punitive action, o Ensures maintenance and revisions of the Quality Agreement with CMOs.o Perform QMS gap analysis and follow up for effective QMS implementation.o Mentor and coach members of site and actively promote an engagement and compliance culture.o Lead projects at the site with appropriate line managers and measure the projects to provide regular KPI metrics. o Ensures timely release of finished products by providing resolution to all issues.o Lead audits at the CMO and direct technical discussions and present information to wider forum.
EDUCATION
Vijaya Mary High School (VMHS).Bodhan
SSC
Osmania University
B.sc Industrial Microbiology
Kakatiya University, Warangal
M.sc Microbiology
Sri Vijaya Sai Junior College
Intermediate
ABOUT ESHWARA CHARY ALLEPALLY SAMBOJU
I am a resourceful and goal-focused professional with 16+ years’ experience involving in External supply manufacturing, Quality control and Quality assurance activities for the pharmaceutical finished dosage forms.I have proven track record of devising effective strategies for improving existing manufacturing process by identifying defective areas, to ensure higher-quality products. As part of CMO management, I Lead and coordinate with CMO for manufacturing of pharmaceutical products and their continual improvements to facilitate release of safe and high-quality medicines to patients on time.I am an articulate communicator possessing excellent problem-solving and analytical skills with a keen attention to detail. I am knowledgeable in change management, deviation management, investigations, root cause analysis, and CAPA.Skills: Exceptionally well organized, Resourceful in making contribution to New Projects/Renovation and Ability to resolve difficult situations under strict timelines and pressure. Experience in Microsoft (Word, Excel, Power Point), Trackwise, Veeva, Agile, Minitab, SAP, LIMS, LMS. Formulations (Drug Product):Ampoules, Vials, Lyophilized Products, Pre-Filled Syringes, and Drug Substance (API)Audits faced:USFDA, MHRA, ANVISA, TGA, Customer audits (Pfizer, GSK, Zoetis, Novartis and Baxter)
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