555 Csv Jobs - Page 12

Overseeing all training activities to ensure team competency and compliance. Help in Conducting audit planning and executing audits of various applications and departments. Reviewing validation documents to ensure compliance and accuracy. Performing peer reviews of audit plans, reports, and observations, and effectively communicating with auditors to clarify findings, ratings, and supporting evidence. Managing change requests, deviations, quality issues, CAPA (Corrective and Preventive Actions), effectiveness checks, and conducting root cause analysis. Assisting in the development of Key Performance Indicators (KPIs) for Quality Management System (QMS) performance monitoring and management o...

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD,...

Tech stack GCP Data Fusion, BigQuery, Dataproc, SQL/T-SQL, Cloud Run, Secret Manager Git, Ansible Tower / Ansible scripts, Jenkins, Java, Python, Terraform, Cloud Composer/Airflow Experience and Skills Must Have Proven (3+ years) hands on experience in designing, testing, and implementing data ingestion pipelines on GCP Data Fusion, CDAP or similar tools, including ingestion and parsing and wrangling of CSV, JSON, XML etc formatted data from RESTful & SOAP APIs, SFTP servers, etc. Modern world data contract best practices in-depth understanding with proven experience (3+ years) for independently directing, negotiating, and documenting best in class data contracts. Java (2+ years) experience ...

Urgent Opening for ETL Testing Opening - Software - Bangalore Posted On 17th Jun 2016 12:12 PM Location Bangalore Role / Position ETL Testing Experience (required) 4 plus years Description Our client is a start up founded in 2009, develops products and solutions in Customer Success Management (CSM). They've received a $54 million venture funding since 201 2 and are expanding their team. They've a 130+ member team (Hyderabad + US). Position: ETL Testing Location: Bangalore Experience: 4 plus years(exp in SQL Queries) Job description Reading and writing data to S3 buckets/MongoDB/Redshift Data migration from one db to another Checking the DB performance Very good at writing SQL queries Good un...

Immediate Openings on CSV Analyst _Bangalore Experience : 5+ Skill:- CSV Analyst Location : Bangalore Notice Period :- Immediate . Employment Type: Contract . Job Description: Key Skills: - Application/Product development testing and experience in Computer Systems Validation (CSV) - Experience in QMS, Regulatory Requirements, GxP Compliance, and Good Documentation Practices - Strictly adhereing to Business SOPs, cost & coverage, requirement specifications & formulation of Test Cases in HP ALM for the Functional, Integration, end-to-end, Usability, and smoke testing. - Experience in the development of Qualification test scripts (IQ,OQ, PQ and VSR) for CSV projects - Good knowledge of CSV, GAM...

Knowledge over BTP cockpit and tenant setup.o Understanding on migration assessment toolo Experience on cloud connector setupo Experience in custom interface implementationo HTTP, FTP/SOAP, OData, REST, JMS Adaptoro Experience in web service interface implementationo Key based and certificate-based authentication.o XSLT, Message mappingo Groovy, Java scriptingo Data Converters (XML, JSON, CSV)o PGP Encryption, Decryptiono Experience in CPI Pre-packaged interface configurationo Handling "Manage

You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones an...

Employee type : C2H Position of the role The role reports into the Global Account Director and is part of the Global Customer Success Team. Result expectation in terms of result areas and core activities The Customer Success Integration Manager will define and deliver the data & integration configuration of the Clients tool within the scope of the Statement-of-Work that will bring value to the customer, is in use and accepted by that customer, complies with the Clients blueprint and is properly handed over the Customer Engagement Department at project closure. Main objectives of the role Pre-Project Assessment: Support the Integration Lead and other involved people in defining the Statement-...

Employment Type: Contract Working Mode : Hybrid 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

Ultragenic brings together Life sciences domain expertise, Third party system knowledge and Deep technology to develop well-defined solutions, which address challenges across the Pharmacovigilance function. Our solutions are agile, flexible and scalable, developed using advance technologies such as AI, Machine learning and Robotic process automation that enable us to serve large and small organizations, both in developed and emerging markets. With rich experience in engineering and deploying best-in-class life sciences solutions, our team is well placed to help achieve your goals. Skills Experience of design, development and deployment of multi-dimensional reports using any BI Tool preferabl...

I nviting applications for the role of Principal Consultant CSV Analyst In this role, CSV Analyst will prepare and execute test documentation for computerized systems and provide support in the troubleshooting of issues during test execution. Responsibilities Assist with the development of system requirements and specifications to ensure requirements that are testable, and 21 CFR Part 11 requirements are met Evaluate proposed changes to validated computer systems and recommend level of validation activities required Identify and qualify all computer systems which impact cGMP operations using a risk-based methodology Develop CFR Part 11 computer systems validation plans, qualifications test p...

Candidate must have hands on experience in Werum PAS-X/FTPS/Syncade/Opcenter development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES compon...

Candidate must have hands on experience in Werum PAS-X/FTPS development. Candidate shall work with end user team to establish requirement specifications e.g. URS, FRS Support the team in the business process mapping, requirements analysis, scope definition. Responsible for creating and revising batch records Extensive software Design, Develop, Commission, and Validate MES applications using MES platforms primarily on Siemens OpcenterTM, experience on other MES system such as Rockwell FTPS, Emerson SyncadeTM MES and/or Werum PAS/XTM, Aspentech, Rockwell etc. will be added advantage. Act as a Subject Matter Expert for Design and Development of workflows, and various MES components such as EBMR...

HIRING FOR FORMULATION UNIT - INJECTABLE/ OSD JOB DESCRIPTION AND EXPERIENCE: WORK LOCATION: Hetero Labs Limited, UNIT V & VI, Polleypally, Jadcherla, Mahabubnagar PRODUCTION(OSD) Experience: (02-07Years) Compression, Granulation, Coating, Capsule filling, Inspection PRODUCTION (INJECTABLE) Experience: (02-07Years) Autoclave, Compounding, filling, QMS, Vial Washing, Lyophilizer, Visual Inspection PACKING (INJECTABLE/OSD) Experience: (01-05Years) Blister Packing, Bottle Packing. QC & QC- Micro Experience: (02-07Years) HPLC, GC, RM,PM, Stability, IP/FP,MLT, Environmental monitoring, QA-INJECTABLE Experience: (02-07Years) IPQA, Validation, Qualification, CSV, AQA (QC & Microbiology) WAREHOUSE E...

Job Title: CSV Analyst (Computer system validation) Location: Hyderabad Exp level: 7-10 Years Work mode : Work from Office Shift Timings: UK Shift Primary Skill: CSV (Computer system validation) Secondary Skill: Pharma IT Quality

Data Quality Analyst (Exp. 6-10 years) Key Responsibilities: Review data extracts (CSV, GeoPackage) via FME or internal systems. Analyze quality dashboards to identify patterns of data issues, including: Textual issues: incorrect/missing IDs, invalid relations, address mismatches, date inconsistencies. Spatial issues: invalid geometries, overlaps, incorrect boundary placements, zero-area polygons. Classify and prioritize issues by severity and type. Translate dashboard insights into clear, actionable instructions for the Operations team to resolve. Collaborate with Data Engineers to update validation rules and dashboards as needed. Maintain issue logs and validation reports for audit trail a...

Well experience Computer system validation (CSV) in API/formulation organisation, Preparing all validation document (i.e URS, GxP assessment & SLRA, Configuration specification, IQ, OQ, PQ, RTM, VSR, DRP) through validation tool as per GAMP 5 & 21 CFR Compliance or Manufacturing and Quality Control Laboratory Equipment. Validate newly/upgraded software in QC Laboratory/manufacturing. Preparation periodic review & Vendor Assessment for Manufacturing and Quality Control Laboratory Equipment Initiate QMS document in Manual/Software base i.e : CCF, Risk assessment, Deviation etc. Solving the issue occurred during the execution. Data Migration and System Retirement activity triggered for manufact...

Maintenance and Projects in API division Candidate having Good Knowledge of CSV Validation as per GMP-5 Green Field and brown field project knowledge Knowledge of instrumentation calibration like , TT,PT,FT,RTD operation and maintenance of all pharmaceutical control instrumentation, Programming and troubleshooting. Designation : Officer/Executive/Senior Executive Experience: 02-07 years

Responsibilities: * Execute tests using QA tools * Ensure compliance with CSV & SOP standards * Collaborate on training management initiatives * Monitor quality through QMS processes * Report defects promptly Overseeing all training activities . Health insurance Maternity policy Gratuity Provident fund Maternity leaves Paternity leaves Job/soft skill training

Responsibilities: * Conduct quality assurance activities using CSV, QMS, SOPs. * Collaborate with teams on training management. * Ensure compliance with industry standards through QA tools. Health insurance Maternity policy Gratuity Provident fund Maternity leaves Paternity leaves Job/soft skill training

Role & responsibilities Job Responsibilities/Descriptions 1.0 Working / Real time experience on Digital platforms like DMS, TMS, ERP, LIMS, QMS and different application software used in production and QC. 2.0 Knowledge on 21 CFR PART 11, GAMP guidelines. 3.0 Provide expertise and guidance to the project/cross function team on computerized system validation activities to meet GxP regulatory needs with focus on Data Integrity. 4.0 To ensure computerized systems validation, and compliance throughout the life cycle of the Equipment/system to comply with the site procedures and Regulatory requirements. 5.0 Preparation of Computerized Systems Validation Master Plan and Gap assessment (if required...

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least ...

Over 5+ yrs exp in Sterling Integrator, EDI X12, map dev (XML, EDIFACT, IDOC, CSV), partner onboarding, logistics EDI (204, 210), BP dev, MFT, and daily EDI ops with B2B/ERP teams. contact no : 9063478483/9063478481

Work Experience :4 to 8 Years. Work Timings: Rotational Shift. Location: Remote. Spektra Systems is seeking a support specialist for providing technical support for trainings and events happening through it’s platform CloudLabs. You’d be a part of a dynamic team responsible for building and supporting many of labs and workshops every month. This profile is for technical support to instructors and learners doing Microsoft Azure, Microsoft 365 and related technologies lab.. This role is perfect fit for someone interested in becoming a technical journalist (jack of all), 50% of your time will go in learning modern cloud technologies and rest 50% in supporting them.. Responsibilities:. Learn and...

Mode of Work : Hybrid Location : Pune, Bangalore, Hyderabad, Pune, Noida, Gurgaon, Chennai, Kolkata, Skill Set : Computer System Validation (CSV ), Veeva Vault , Trackwise , Argus The opportunity Were looking for Senior with expertise in Computer System Validation and stakeholder management to join our Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your key responsibilities Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach. Integrate technology with business process transformation programs l...