Highlights:

Skills:

Manufacturing Operative 12/2020 - 06/2021
Jabil Healthcare, Bray, Wicklow Ireland
Industry: Medical Device
• Inspecting In-process components according to SOPs in a cGMP environment. Reporting Deviations in operations and Instrumentation to the supervisor.
• Authoring quality deviation reports and managing change controls and CAPA related and process improvements. • Exhibiting quality testing including leakage testing of the device. Deputizing team leader in the preparation of SAP documentation for batch release. • Preparing and labeling the samples for QC testing. Recording & procurement of medical components that facilitate smooth production. Ensuring manufacturing operations comply with GMP and EMA regulations. • Demonstrating complete knowledge of manufacturing processes and equipment while leading continuous improvement initiatives to improve performance indicating metrics. • Leads problem solving / root cause analysis initiatives to eliminate defects and waste; leads the implementation of subsequent preventive actions. Training technicians and mechanics on lean concepts, zero loss culture, ownership culture, and equipment operating principles relevant to job function. • Assisting in development of Quality Assurance test project strategies, Analysis (FMEA), Root cause methodologies and standard processes. • Creating and maintaining equipment and process troubleshooting guides, operating procedures and equipment settings. • Key contributions: Achieving the target production of 5 batches and increasing productivity. Identified and eliminated quality defect medical device components and reported to team leader.--
Quality Control Specialist 07/2018 - 08/2019
Arene Life Sciences, Hyderabad, Telangana India
Industry: Pharmaceutical
• Performing Analytical testing for batch release on in-process products, finished products, raw material, and validation samples as required for API manufacturing while adhering to GLP and GMP guidelines.
• Expertise in Analytical testing of samples using Empower 3 HPLC (Waters)/GC Systems, Dissolution Apparatus, Karl Fischer and UV spectrophotometer, FTIR, Auto titrator, pH meter, Density Metter and Osmometer. • Participated in equipment commissioning, decommissioning and validation activities with validation personnel. • Supported validation team in Cleaning Validation (CIP) Activities in production area. Verifying and documenting the CIP temperature and cleaning time activities. • Authored relevant standard operating procedures (SOP) for ensuring compliance with the company’s policies. • Reviewed and assisted in Investigating deviations related to Laboratory test failures and Laboratory Instruments. • Initiated change controls and reviewed/approved change controls using QMS systems. Managed QC change controls, CAPA’s and supported operational readiness. • Understanding of Lean Six Sigma principles and involvement in continuous improvement activities of QC laboratory. • Supporting critical raw material/stability sample management activities (Reference Standard/QC Assay control/Inventory management and reserve inspections. • Utilized Laboratory Information Management System (Labware LIMS v6) for test sample Inventory and sample test result reporting. COA creation and providing training on LIMS to other users. • Maintained cGMP lab readiness and compliance at all times including equipment maintenance and calibration.--
Intern Clinical Pharmacist 07/2017 - 06/2018
Lalitha Super Speciality Hospital, Guntur, Andhra Pradesh India
Industry: Healthcare
• Conducted Safety Operations, ADR reporting for drugs, Maintenance of Logbook, and Clinirex Documentation. Product quality review (License). Investigated Customer Complaints.
• To assist the Supervising Pharmacist in meeting operational standards and implementing company initiatives. • Work with the team to find better care solutions for customers and patients. • Assisted in the professional, clinical, ethical and financial running of the hospital pharmacy in line with company and industry regulations. • Mentored Juniors on Clinical Operations and provided administrative support to the hospital.--

Acharya Nagarjuna University 10/2012 - 06/2018
Guntur, Andhra Pradesh, India
Degree: Bachelor's Degree
Major:Pharm.D
Pharmacotherapeutics, Formulations, testing processes, Pharmaceutics, Pharmaceutical Analysis, Stability of Medicines, Pharmaceutical Organic & Inorganic Chemistry.

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