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4 - 8 years
13 - 17 Lacs
Hyderabad
Work from Office
In this role, you will: Lead or participate in moderate to high risk or complex review activities in a matrixed environment and communicate emerging risks to management within Independent Testing Contribute to large scale planning related to Independent Testing deliverables Review and research moderately complex potential corrective actions, and follow through on reporting, escalation, and resolution Ensure effective and appropriate testing, validation, and documentation of review activities for risk programs and controls according to standards and other applicable policies Resolve moderately complex issues and lead team to meet Independent Testing deliverables while leveraging solid understanding of risk management framework and the risk and control environment Collaborate and consult with colleagues, internal partners, management and lines of business regarding risk management Required Qualifications: 4+ years of Independent Testing experience, or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education Desired Qualifications: Strong Excel and Power point skills Should have good exposure in Compliance and Risk Job Expectations: Work timings would be 1:30 PM to 10:30 PM 11 May 2025 Wells Fargo maintains a drug free workplace. Please see our to learn more.
Posted 1 month ago
3 - 8 years
5 - 9 Lacs
Ahmedabad, Bengaluru
Work from Office
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 Bangalore Search : Validation Associate Bangalore (Job Code # 173) b) For Position in Ahmedabad Search : Validation Associate Ahmedabad (Job Code # 175)
Posted 1 month ago
- 5 years
4 - 8 Lacs
Visakhapatnam, Hyderabad/Secunderabad
Work from Office
Job Description The scope of work for this role is to provide QA Validation support to validation activities associated with of Laboratory instruments and Manufacturing equipment in pharmaceutical industry. The responsibility includes review and approval of Qualification/Validation documentation DQ,IQ,OQ,PQ including Risk assessment, specifications, executed protocols, summary reports, deviations, periodic reviews, procedures, and change controls. In addition, this role may provide support to the sites data integrity initiative. Successful candidate requires a strong working knowledge of global cGMP with an emphasis on validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures Candidate requires strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QA Validation/Qualification personnel. Candidate must be detail oriented as the main job responsibility is review and approval of validation documentation Should also have some experience in Mechanical Qualification Job Requirements Skills: Strong working knowledge of global GMPs with emphasis on validation, including computer validation Strong interpersonal, oral and written skills Detail oriented Education: Candidate must have at a minimum a BE or equivalent, engineering or related sciences with pharmaceutical or biopharmaceutical experience in a quality assurance and/or validation/Qualification role. Past experience working with Equipment Qualification, Quality Management system, Document, Document Management System, Track wise, and etc. Experience working with process manufacturing equipments (RMG, Sifter, Blender, compression m/c, Capsule filling m/c & etc), Utility (Water system, HVAC & etc) and other lab instruments is a plus.
Posted 1 month ago
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