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3.0 - 5.0 years
5 - 15 Lacs
Bengaluru
Work from Office
Responsibilities: Performing requirements analysis to develop overall testing strategy & individual test cases & protocols. Identify testing requirements & dependencies Work with relevant experts for generating testing Jigs and dependencies Performing unit testing, integration testing, and pilot unit verification and validation for all Electronic/Hardware/Embedded/Mechanical/Optical subsystems. Handle all V&V documentation including creating and maintain verification test plans & generating final reports. Work with design team to debug issues and perform root cause analysis. Coordinate with regulatory teams for identifying & performing 3rd party tests. Perform Component level validation and ...
Posted 6 months ago
2.0 - 4.0 years
2 - 4 Lacs
Bengaluru
Work from Office
Dear All, We are looking for as Junior Engineer - Tool & Process development for GTTC, NTTF & CIPET holders. Job Description. New child parts development (tool and process) to meet master schedule a. Tool spec review, Tool design review b. Inspection report review c. Tool Correction plan review d. Schedule review e. Handover tool and process f. Co-ordinate with CFT to get and share information related to NPD g. Develop facilities that is unique for the part ECI implementation and monitoring Adherence to IATF requirement Master list control QCPC,PCA,FMEA,SMH, gauges, fixtures, trim tools, dies, moulds, part weight, shot weight, RM details. Meet the IOC requirements given by PC Follow Safety r...
Posted 6 months ago
5.0 - 8.0 years
3 - 8 Lacs
Ahmedabad
Work from Office
Role & responsibilities Validation & Qualification of Equipment Experience in Autoclave, Terminal, Sterilizer, Mixing Vessel, Tunnel Qualification, washing machine and filling machine. HVAC Qualifications Validation and qualification protocol and report. To ensure material issuance for validations activities & keep Section Manager updated. To ensure implementation of validation, qualification activities & inform to Section Manager for any deviation from written procedure. Equipment Qualification Steam Heat Sterilizer, Terminal sterilizer, Preferred candidate profile:- Result orientated Communication skills Presentation skills Analytical skills Lateral coordination * Candidate can share their...
Posted 6 months ago
2.0 - 5.0 years
0 Lacs
Bengaluru
Work from Office
Job Role: CQV Engineer Experience: 2-4 years Location: Bengaluru Key Responsibilities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO) Should have sound knowledge in good documentation Pr...
Posted 6 months ago
6.0 - 10.0 years
8 - 15 Lacs
Mumbai
Work from Office
Role & responsibilities MAJOR ACCOUNTABILITY (Mention core tasks assigned to associate etc.) 1. Preparation of Qualification documents for Pharmaceutical HVAC system. - URS, DQ, IQ, OQ, PQ 2. Execution of HVAC modification projects 3. Review of HVAC assessment reports for modification scope of HVAC systems 4. Review of BOQ for HVAC modification 5. Preparation of URS for Air Handling Systems 6. Preparation of QRA & CR for HVAC modification projects 7. Review of HVAC layouts i.e. System zoning, Pressure Zoning, Area Classification drawings 8. Review of Heat Load calculations 9. Integration of new AHUs with BMS system & BMS system qualification 10. Creation of Maintenance plan, Calibration plan...
Posted 6 months ago
3.0 - 8.0 years
5 - 9 Lacs
Mumbai, Indore, Pune
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...
Posted 6 months ago
2.0 - 7.0 years
2 - 7 Lacs
Visakhapatnam, Hyderabad
Work from Office
Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Assurance Executive & Sr.Executive injectables&OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1.IPQA 2.QMS 3.AQA 4.Validation 5.Equipment Qualification 6.CSV 7.Market Complaints. The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in or feel free to call on 6305391924 Thanks and Regards Prasanthi - Dashboards Team HR
Posted 7 months ago
4 - 9 years
0 - 0 Lacs
Bengaluru
Work from Office
Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of chan...
Posted 7 months 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...
Posted 7 months ago
2.0 - 7.0 years
3 - 6 Lacs
ahmedabad
Work from Office
Job Description QA-Qualification Injectable /Parenteral (Officer/Senior Officer/ Executive) Job Location Sanand, Ahmedabad (Injectable Facility) No of Position - 03 Total Experience - 2-7 Years in Injectable Manufacturing Education B. Pharmacy/M. Pharmacy Will appreciate immediate joiner for this role Oversight and Governance QA ensures that all qualification activities (DQ, IQ, OQ, PQ) follow Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., US FDA, EU GMP, WHO). Participates in project planning for qualification activities. Reviews and approves Qualification Master Plan (QMP). Document Review and Approval: QA is responsible for reviewing and approving all qualification do...
Posted Date not available
3.0 - 5.0 years
5 - 6 Lacs
bengaluru
Work from Office
Role & responsibilities Review of the executed manufacturing documentation at contractual partners and ensure its compliance with internal Quality Management System and applicable Regulatory Guidelines in cooperation with Quality Management at Krka. Reviewing the manufacturing documentation of pharmaceutical products and identifying potential errors or irregularities. Participates in investigation of deviations, complaints, unfavorable trends, and OOS results with contractual manufacturers. Participate in harmonization of applicable change controls. Takes part in organizing audits of our contractual partners in line with the audit plan and monitors its realization. Monitors the manufacturing...
Posted Date not available
4.0 - 8.0 years
2 - 5 Lacs
dadra & nagar haveli
Work from Office
We are hiring for the role of QA - Executive at JLL!! Department: Quality Assurance Location: Silvasa Engg. Division, Silvasa Experience Range: 4 to 5 Years Qualification: Post Graduation Diploma in Plastic Processing and Testing from CIPET Role & responsibilities Making the required standard quality documents, reviewing and ensure to implement at Silvasa Engg. Division. Strong technical Process knowledge on Packaging Machines as well as good understanding of mould validations Protocols. Basis coordination with all the QA personnel at all the units and with Corporate QA team. Coordination with Corporate Quality Team for packaging samples for continuous quality evaluation. To handle all marke...
Posted Date not available
4.0 - 8.0 years
2 - 5 Lacs
dadra & nagar haveli
Work from Office
We are hiring for the role of QA - Executive at JLL!! Department: Quality Assurance Location: Silvasa Engg. Division, Silvasa Experience Range: 4 to 5 Years Qualification: Post Graduation Diploma in Plastic Processing and Testing from CIPET Role & responsibilities Making the required standard quality documents, reviewing and ensure to implement at Silvasa Engg. Division. Strong technical Process knowledge on Packaging Machines as well as good understanding of mould validations Protocols. Basis coordination with all the QA personnel at all the units and with Corporate QA team. Coordination with Corporate Quality Team for packaging samples for continuous quality evaluation. To handle all marke...
Posted Date not available
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