30 Equipment Validation Jobs - Page 2

Creation/modification of process flows within the Manufacturing/Service Departments. Remediate Manufacturing, DHF, DMR Documents of new and legacy products to current organization standards and policies. Perform gap assessment and conduct remediation of documents with stakeholder inputs. Development and maintenance Manufacturing/Service Work Instructions and related documents. Creation/modification of fixtures, tooling, equipment and systems to support operations. IQ, OQ, and PQ of fixtures, tooling, and equipment. Identify, investigate, and resolve operational issues to improve First Pass Yield and reduce waste. Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions. Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation. Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred. Must be able to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment. Experience with statistical software packages (Minitab is a plus), SAP, windchill, onePLM etc. Experience with Quality Systems and process controls in the medical device industry is desirable. Knowledge and working application of FDA, cGMP, ANSI/ISO/ASQC requirements. Knowledge and working application of technical part drawings and GD&T principles. Demonstrated application of engineering principles on individual/small projects and ability to work with cross functional teams to successfully implement quality improvement and cost reduction initiatives. Demonstrated strong analytical problem solving Root Cause Investigations, CAPA, Six Sigma, continuous improvement projects. Ability to multi-task and methodically lead/manage projects. Location: Chennai Required Skillset: Gap Assessment and Remediation for DMR, Class 2 and 3 device

Hi, We are hiring for Leading ITES Company for Validation Associate Profile. Job Description Minimum 3 years as a Validation Associate is required. 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification (DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through the entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failures. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenarios. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare the InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slice variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets Document inconsistencies Key Skills: a) Min 2 years of experience in eDC or non eDC b) Edit checks validation & script creation in any eDC systems like InForm, Veeva, Rave is required c) Any Graduate WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 173 b) For Position in Ahmedabad Search : Job Code # 175

Carrying out maintenance activity and provide necessary to the General Injectable, OSD & Oncology block as and when required. preventive maintenance, breakdown maintenance.Carrying out qualification activities like IQ/OQ/PQ and forms filling as per Required Candidate profile Documentation Work as per GMP, record keeping, maintaining spares Generating change control & deviations as per plant/site requirement Handling of all the QMS activities as per plantsite requirement

Hi, We are hiring for ITES Company for Validation Associate Role. Job description ***Minimum 3 years as Validation Associate is required.*** 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Validation Associate Mumbai (Job Code # 171) b) For Position in Pune Search : Validation Associate Pune (Job Code # 172) C) For Position in Indore Search : Validation Associate Indore (Job Code # 174)

To prepare and review Validation Master Plan (QMP, VMP, PVMP, CVMP and CSVMP). To follow the validation master plan.To prepare and review qualification and validation documents and execution as per protocol. Required Candidate profile Preparation&review of URS,FS,DS,DQ,RA,IQ, OQ&PQ & summary reports for Equipment, System&Utilities.Handling & storage of all quality document like BMR,BPR,log book, protocol & SOP throughout life cycle