16 Equipment Validation Jobs

Roles and Responsibilities Conduct quality audits, BMR reviews, CAPAs, deviation investigations, change controls, equipment qualifications, process validations, and vendor qualifications. Ensure compliance with USFDA regulations through IPQA activities Engineering Documentation ,Qualifications &Validations. Warehouse Documentation ,Qualifications &Validations. Cleaning Validation Perform analytical QA tasks such as OOS management and sterility testing. Participate in MHRA / USFDA inspections by providing necessary documentation and supporting audit findings. Collaborate with cross-functional teams to resolve quality issues. Regulatory Audit Exposer LIKE FDA, MHRA, TGA Audit Reponses and Audit Reediness if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com

Objective: Perform an adequate calibration operation based on SAFRAN standards as well the management of the calibration premises, tools and spare parts Role & responsibilities Follow, maintain and manage under control the tooling calibration activities as required by the related processes and requirements Perform the tooling maintenance and/or calibration per the required standards and the defined schedule Ensure external calibration tools control including related records Ensure proper tooling identification and calibration status Produce accurate and reliable calibration records and ensure its integrity Ensure proper management of calibration system/software Ensure proper tools, equipment and spare parts handling Ensure proper care and management of tools inventory under calibration, including tools integrity Ensure proper care and management of calibration spare parts Prepare documentation, charts and reports as required by the relevant processes Support operations and quality activities as required Identify and propose improvement opportunities Perform all Health, Safety & Environment(HSE) related duties as per his / her job requirements and follow HSE norms as applicable. Preferred candidate profile 2- 4 years of experience performing calibration activities is desired Experience working under ISO 9001 or AS9100 quality systems and environmental systems Professional Skills MS Office proficiency Good knowledge of Excel Basic problem-solving tools such as: Fishbone, 5 Whys, etc. Fluent English writing and speaking proficiency Behavioral Skills Work under pressure Self-motivation Team player Desirable Aspects QS Metro system Inventory management FAI knowledge SPC, ISO 9001, AS 9100, ISO 17025 knowledge

Involving in Validation of Batches and Qualifications of equipment's Carryout In process & review of all packing IPQA activity of Tablets, Capsules and soft gel area Calibration of Balance and all IPQC instruments. Ensuring that all Log sheets & Records are updated on-line Issuance and Review of BPR & SOPs with the operation. Line clearance related works before starting of production activity Equipment Qualification

1. Utilize a broad understanding of cGMP to provide QA support, mentoring and coaching for Operations, Analytical, Logistics and Engineering departments to assure that activities are undertaken in compliance with cGMP and procedures, as appropriate. Required Candidate profile GMP PRO/DATA NIJNA/BMR/ANNUAL PRODUCT REVIEW/MBR/CLEANING VALIDATION

Role & responsibilities Validation & Qualification Oversight Prepare and maintain Validation Master Plans (VMP) in alignment with corporate and regulatory guidelines. Review and approve qualification documentation including URS, DQ, IQ, OQ, PQ, RQ , ensuring completeness and compliance. Supervise execution activities and guide the team during validation and qualification stages. Oversee and review Performance Qualification (PQ) , Requalification , interim and summary reports , and addenda . Documentation & SOP Management Develop and review validation protocols , SOPs, and QA documentation related to equipment, facility, and utility qualification. Review and ensure compliance of SOPs from other departments that impact validation and qualification processes. Ensure proper documentation control, including version management and approval routing. Project Management & Execution Ensure timely completion of validation activities in alignment with project milestones and regulatory timelines. Review layouts and engineering drawings for facilities, utilities, and equipment to ensure compliance and suitability for intended use. Maintain and oversee revalidation schedules in accordance with change control and periodic review programs. Deviation & Change Control Handling Investigate and document validation-related deviations and change controls , recommending and implementing appropriate corrective and preventive actions (CAPAs) . Collaborate with cross-functional teams to resolve validation and qualification issues proactively. Training & Team Development Mentor and train QA validation team members on current practices, regulatory expectations, and internal standards. Conduct knowledge-sharing sessions to build team capability in equipment, facility, and utility validation . Compliance & Continuous Improvement Ensure cGMP compliance in all validation and qualification activities, maintaining a validated state at all times. Continuously evaluate and improve validation systems, practices, and documentation to meet evolving regulatory requirements. Preferred candidate profile Bachelors or Master’s degree in Pharmacy with 8–12 years of relevant experience in QA Validation within a regulated injectable manufacturing facility . Proven expertise in equipment / facility / utility qualification , process validation , and cleaning validation . Strong knowledge of regulatory guidelines : cGMP, 21 CFR Part 11, EU Annex 1, WHO TRS, ICH Q8-Q10. Experience in deviation handling , change control , and validation risk assessments . Ability to read and interpret engineering drawings , layouts, and P&IDs. Hands-on experience with documentation systems and quality management systems (QMS).

Role & responsibilities Sr.Executive : QMS & engineering documentation Primary Responsibilities: 1. Responsible for GMP compliance, as per procedures define and implementations of GxP practices. 2. To ensure the GDP and data integrity in routine/daily activities/operations. 3. Responsible for QMS documents related to engineering. 4. Audits & compliance 5. Preparation of SOPs, review & periodic revisions 6. To attend /or supervise all jobs related to Electrical/ Instrumentation Engineering activities at site. 7. Timely execution of equipments/instruments as per schedule coordination with user. 8. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 9. Maintain the Spare parts of all critical Instruments in site. 10. Timely execution and completion of Validation/ Qualification activities at site. 11. Execution of all In-house Projects in Electrical/ instrumentation in site. 12. Maintain the calibration logs, area /equipment logbooks, preventive maintenance schedule of all the activities. Preferred candidate profile

Role & responsibilities: Developing Validation Documentation and support for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems) Developing Validation Documents and Execution of Validation Protocols. Validation Documentation will encompass validation plans, specifications, test protocols and standard operation procedures. Systems include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure. Preferred candidate profile Candidates must have experience/exposure to Computerized System Validation (CSV) especially PLC Validation 21 CFR Part 11, EU Annex 11 and GAMP 5. Good communication and technical writing skills are a must. Candidate should be ready to travel within Gujarat.

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 System level validation. Coordinate with clinical/applications specialists to complete clinical validation/evaluation/investigation as required. Preferred Skills: Strong analytical & abstract thinking, problem solving, creativity. Excellent oral, written communication skills. Prior experience participating in various activities associated with verification & validation of medical devices. Usage of test management tools including JIRA and others. Knowledge of Process Validation, Tools/Jigs/Fixtures Validation and Equipment Validation. Expertise in process & test automation and control. Comfortable with Arduino, python, Node js, C++. Comfortable interpreting PCB schematics & gerbers, drawings, & PRD. Fluency with Excel, Word, Jira, Notion.

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 rules Continuously improve the process by nurturing the spirit of originality, enthusiasm and innovative challenges Work in harmony within department, with other departments and vendors to solve the problems. Implement gorika. Actively participate in suggestion scheme. Interested candidates can send resume at manohara.is@trmn.biz

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 resume at anee.silas@otsukapharma.in

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 Practices and QMS process throughout the CQV lifecycle. Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution. Provide technical input during project planning and scheduling of CQV activities. Track and report progress of CQV milestones, and support. Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures) Coordinate and interface with operations and quality assurance department, to develop supporting documentation, execution plans, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations. Initiate and manage validation deviations in the testing of development process and equipment functioning. Analyze the investigations to identify the root cause of the deviations to define a corrective action. Ensure efficient operation of the pharmaceutical equipment to corroborate the drug quality meets clients standards, GMP and FDA regulations. Perform design review to ensure the equipment is installed and operates according to the user requirement specification.

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 for the HVAC systems 11. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 12. Completion of all trainings assigned to role 13. Ensure integrity of data at workplace. 14. Ensure Good Documentation practices at workplace 15. Involvement in Detail Designing, Concept phase in Major/Minor Projects, Supervising and instructing third party contractor work 16. Weekly meeting with cross functional team to meet project timeline. 17. Daily startup meeting with team for complete project within timeline and to identify points which may impact on completion of project. 18. Vendor alignment to complete project timely and Vendor follow -up to timely resolve project problems 19. Handover area of equipment within define timeline to avoid process impact and Coordinate with cross functional team to complete project within timeline 20. Preparation of qualification document timely and Timely completion of project compliance action 21. Complete project within timeline with 21 CFR part 11 compliance and as per qualification sop. 22. Qualification documentation should prepare and execute with 100% accuracy without GXP error 23. All QMS actions should be completed within the assigned date. 24. Continuous improvement related to engineering to be initiate and complete at least 2 per year which will help to save R&M and time. 25. Installation and commissioning of FDF equipment as per GMP and Carrying out qualification activity as per SOP. Company : Sandoz Healthcare Location : Mumbai ( Kalwe ) Contract role and will be renewed yearly based share resumes to nedunuri.saikumar@manpower.co.in

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 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 171 b) To Apply for above Job Role ( Pune ) Type : Job Code # 172 c) To Apply for above Job Role ( Indore ) Type : Job Code # 174

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

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 change controls, deviations, Investigation and CAPAs and closure of the same. Tracking of QMS activities and coordinating with cross functional departments to complete the QMS activities like investigation for OOS, complaints, deviations. Identification, preparation and implementation of SOP’s. This position will prepare SOPs related to the machines which are undergoing commissioning and procedures which are proposed to implement in Drug product area. Preparation and review of URS, CLIA, SLIA, QRM, IQ and OQ documents. Involvement in the qualification activities of equipment and area in drug product area People: Champion the OneSource Core Values and lead by example by acting a member of a team to achieve organizational and common objectives. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan. Preparation and execution of training modules on SOP’s in the department. Preparation and execution of QMS documents in the department. Preparation and execution of training modules on QMS and safety SOP’s in the department. Preparation and execution of training on soft skills to develop the team. Finance: Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product, process or site.

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)