3.0 - 7.0 years

0 Lacs

karnataka

On-site

You should have a minimum of 3-4 years of experience in pharmaceutical Commissioning, Qualification, and Validation (CQV). Your responsibilities will include: - Authoring commissioning protocols for equipment and utilities like Reactors, centrifuges, dryers, HPLC, etc. - Coordinating with engineering and Original Equipment Manufacturers (OEMs) for Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). - Developing documents such as Design Qualification (DQ), System Impact Assessment, and Risk Assessment in collaboration with OEMs. You will also be required to: - Create, review, and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for process equipment. - Ensure that qualifications are conducted in compliance with regulatory standards such as FDA and WHO. Additionally, you should possess: - Proficiency in good documentation practices and Quality Management System (QMS) processes throughout the CQV lifecycle. - Ability to collaborate with various teams including engineering, manufacturing, Quality Assurance/Quality Control (QA/QC), and Information Technology (IT) to facilitate CQV activities and ensure project success. - Provide technical insights during project planning and scheduling of CQV tasks. - Monitor and communicate the progress of CQV milestones effectively. - Strong project management skills and exceptional communication and writing abilities.,

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Software Test Engineer - GenAI TeraRecon, Inc.

0.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Job Requirements This Role shall be responsible to drive Software Quality for Product features/modules being developed with GenAI Technologies and shall own the quality gates for feature readiness for the Module/Feature. The said role shall analyse the feature requirements and derive the required test strategy & coverage based on the feature impact on all relevant platform components using GenAI Technologies. The incumbent shall closely work with the Product Management & Dev feature owner in reviewing the test coverage & strategy to ensure feature quality. Shall derive the test scenarios & associated test cases from the feature requirements and shall conduct dry runs incrementally on the dev builds to enable feature readiness for verification/validation. Shall be well versed with QMS process and while generating the qualitative test artifacts by self, shall also ensure quality reviews for artifacts generated by other SQA members in the team to enable anytime audit readiness. Should be able to perform first line triage for the issues found and should have attention to detail while reporting issues along with all the supporting information. Should have experience in automating the regression test suites using any of the industry standard test automation frameworks. Work Experience Groom the product features by closely working with the product management and development feature leads to come up with test strategy, test scenarios & test cases. Come up with feature test plans, seek test case reviews from product owner & feature lead to derive optimal test plan for the product features. Perform incremental dry runs for the feature during the design & development phase to help identify issues early in the cycle and collaboratively work with the dev team to drive feature readiness towards verification/validation. Adept with the Organizations QMS and be able to produce quality test artifacts that shall help audit readiness for the product any time. Ability to understand the system workflows, impact of feature updates to other related features in the system and be able to translate that to adequate test coverage to find as many issues as possible during dry runs and verification cycle to avoid issue escapes to the field installs. Act as a quality gate keeper to the feature delivery towards program milestones and un-yielding attitude towards product quality Engage closely with product install team to understand the customer site problems, analyze and plug holes in the SQA test coverage to help strengthen the product quality Show more Show less

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