141 Equipment Qualification Jobs - Page 6

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

At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities,collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow.Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose. The GxP CSV Validation Engineer ensures that digital systems used in clinical development comply with regulatory standards (GxP, 21 CFR Part 11, EMA Annex 11). They develop and execute validation protocols (IQ, OQ, PQ), risk assessments, and documentation to support system compliance and audits. The GxP CSV Validation Engineer ensures that digital systems used in Clinical, Regulatory Affairs, Medical Affairs, and PV Safety comply with GxP, 21 CFR Part 11, EMA Annex 11, and other regulatory standards. They develop and execute validation protocols (IQ, OQ, PQ), perform risk assessments, and maintain compliance documentation. Primary Skills Bachelors or Masters degree in Life Sciences, Computer Science, Regulatory Affairs, Quality Assurance, or a related field Certifications such as Certified Quality Auditor (CQA), GAMP 5, or CSV-related certifications are advantageous Skills (competencies)

Job Description Physical verification and readiness of equipment and instrument for process. Arranging the process accessories and consumables in process area before batch execution. Coordination for dispensing of raw material required for the production processes. Preparation of process, equipment and area related SOPs and EOP s. Preparation of process, area and equipment qualification/ validation protocols. Preparation and execution of various reports like process, equipment, area qualification and validation. Request and Issuance of BPR. Preparation and review of BPR. Preparation and execution of study protocols, URS as and when required Work Experience Four to Seven Years Education Masters in Biotechnology or Biochemistry B.Tech in Biotechnology or Biochemistry Competencies

business development - Warehouse PPC/BD-W/1312211 Contract Logistics PPL Head Office Posted On 16 Apr 2025 End Date 31 May 2025 Required Experience 3 - 5 years ShareApply Basic Section No. Of Openings 1 Designation Grade Assistant Manager - M3 Freshers/Experience Experience Employee Bonus One Month Organisational GPCOMP Pon Pure Chemicals Group Company Name Pon Pure Logistics Private Limited Department Contract Logistics Country India State Tamil Nadu Region Chennai Branch PPL Head Office Skills Skill Sales & Marketing Skills Communication skills Customer Data Minimum Qualification Under Graduate CERTIFICATION No data available Working Language English Hindi Tamil About The Role Person should have experience in business development warehousing business and strong customer data base. person able to convert existing customers on a faced manner. Product knowledge and communication skills are essential capable enough to achieve the targets as per the time frame -from the date of joining within three JC business conversion should take place. .

ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description We are looking for a skilled Validation Associate Analyst to ensure our Master Data Management solutions are of good quality , compliant and GxP validated . As a key contributor, you will collaborate closely with cross-functional teams to ensure that the data mastering solutions and pipelines follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant. Roles & Responsibilities Plan, coordinate, and execute validation activities, including qualification and validation of data products and software applications. ? Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports and get reviewed and approved Ensure validation strategies meet regulatory requirements and company standards Write Installation Qualification (IQ), Operational Qualification (OQ), and Computer System Validation documents and get reviewed, and approved Stay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards. ? Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps , engineering, and data engineering teams to drive validation activities and meet project deadlines. ? Track the progress of validation activities and work closely with the product owner and scrum master to ensure validation activities timelines are aligned with the overall project plan. ? Ensure timely and effective completion of all validation activities in line with project objectives and schedules. ? Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management. ? Identify opportunities for process improvements in validation activities. ? Stay current on new technologies , validation trends, and industry best practices to improve validation efficiencies. ? Collaborate and communicate effectively with the product teams. ? Basic Qualifications and Experience Master’s degree with 1 - 3 years of experience in Business, Engineering, IT or related field OR Bachelor’s degree with 2 - 5 years of experience in Business, Engineering, IT or related field OR Diploma with 6 - 8 years of experience in Business, Engineering, IT or related field Functional Skills: Must-Have Skills: 2 + years of experience in validation in a G x P -regulated environment (pharmaceutical, biotech, medical devices, etc.) Experience of working in software validation projects Strong experience on tools like ALM , JIRA etc Must have worked in Agile or SAFe projects Experience with automated and computer-controlled systems validation (21 CFR Part 11) Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation Candidate must be able to write validation scripts in ALM and execute them independently Experience with computer system validation and software validation is a plus Strong problem-solving and analytical skills Excellent communication and teamwork skills Good-to-Have Skills: Understanding of compliance and regulatory considerations in master data. In depth knowledge of GDPR and HIPPA guidelines . Good to have prior work experience in MDM domain Hand son experience on JIRA, Confluence Professional Certifications CSV Certified Agile or SAFe certified Soft Skills: Strong analytical abilities to assess and improve master data processes and solutions. Excellent verbal and written communication skills, with the ability to convey complex data concepts clearly to technical and non-technical stakeholders. Effective problem-solving skills to address data-related issues and implement scalable solutions. Ability to work effectively with global, virtual teams EQUAL OPPORTUNITY STATEMENT Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Job Description : - Department - Injectable Mfg & Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 6 Education - ITI / Diploma Eng / D.Pharma / B.Pharma / M.Pharma Skill Set - Require good knowledge in Complex Skid / NDDS / Aseptic (PFS / Vials Liquid) / Autoclave/ Lyopholizer / Batch Manufacturing, Sterile Secondary Packing and track and trace activity + visual inspection activity. Department - QC ( QC FG / Stability / AMV ) Position - Officer to Executive Exp - 2 to 7 Education - M.Sc / B.Pahrma / M.Pharma Skill Set - Analyst : Finished, AMV & Stability Section. knowledge of Instrument - HPLC / GC. Preferably know-how of Chromeleon Software Department - Engineering ( Plant Maintenance Sterile / Instrumentation Sterile ) Exp - 2 to 15 Position - Technician / Executive / Assistant Manager / Manager Education - Diploma Eng / ITI / B.Tech Skill Set - Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility Department - QA ( IPQA / Qualification (Sterile Background Only) Position - Officer to Executive Exp - 2 to 7 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Have good exposure in Sterile IPQA & Sterile Qualification Related activity Department - Lab QA Position - Officer to Sr. Executive Exp - 2 to 9 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Having good exposure of QC QMS handling , Lab instrumentation & audit trails. Have strong background of Lab QA activity. Department - Solid Oral Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 5 Education - ITI / Diploma Eng / D.Pharma / B.Pharma Skill Set - Require good knowledge in Primary & Secondary Packing, Track & Trace, Carton Packing Machine (CAM HV1 Model), Online Documentation BPCR / Logbook etc.

To perform and Bioburden test for water, raw material, and Product. Media Preparation required for utility and area monitoring. Sub Culturing, serial dilution of standard cultures and GPT. Environmental Monitoring of all classified areas Operation of decontamination autoclave. To perform SAP and LIMS related transactions as per authorization. To perform Submission and request of records on Doc cell. Preparation and review of Microbiology related SOP s/STP s/Validation protocol and Report. To initiate Change control, Deviation and CAPA related to Microbiology as per QAMS authorization. To monitor temperature data of incubators in Lisaline. To ensure online documentation as per GMP requirement. To perform sterility Testing of RM, PM and Product. To perform Cell bank testing. To perform stability aliquoting To comply with the current & subsequent EHS management system, procedures, guidelines, policy, practices, requirements, and applicable legal compliances on site. Preparation of Microbial Library for in house isolate identified from water and environmental monitoring samples. To perform cell banking system. Daily pH, Balance Calibration and Temperature recording. Cleaning and disinfection of the controlled areas. Sink cleaning. Equipment qualification IQ/OQ/PQ/RQ and PV) / calibration activities related to Microbiology dept. Any other responsibility advised by the superiors from time to time. Work Experience 05 Years of relevant experience Education Masters in Microbiology or Biopharmaceutics Post Graduation in Microbiology Competencies 2. Innovation & Creativity 3. Customer Centricity 5. Result Orientation 6. Process Excellence 7. Collaboration

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.

Develop thorough test plans and document the results and progress Develop in-depth functionality and stability automatic tests that will map customer use cases Research the right set of workloads and benchmarks Develop automated test scenarios and environments for End2End automatic evaluation Collect test evidence measurements to ensure system functionality, stability and scalability Establish automatic measures to assess the accuracy Analyze results to find ways to improve functionality coverage Analyze root causes and identify areas for improvement Collaborate with development teams to drive resolution for issues and improvement Generate test automation summary reports for stakeholders review Required education Bachelor's Degree Preferred education Bachelor's Degree Required technical and professional expertise 8-12 years of test automation development experience 6-10 years of experience in software testing in the workplace 4-6 years experience in Python/Go/Java programming Good English communication skills (written and oral) and be able to work independently and as part of a team. Knowledge of REST technologies is an important advantage. Preferred technical and professional experience Cloud network concepts including software defined networking, virtual private cloud (VPC), network services such as load balancer, firewall, gateway as it fits in cloud network infrastructure Working knowledge of cloud network infrastructure technologies Linux network internals Linux Virtualization technologies relating to network virtualization Kubernetes, Docker Knowledge of bash, go lang, php, awk Working knowledge of Network tools is an important advantage. Knowledge of Windows and Linux operating systems Knowledge of Github and Jira is an advantage. Fast learner and a team player

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 documentation: Design Qualification (DQ): Ensures the design of equipment/facility meets regulatory and user requirements. Installation Qualification (IQ): Verifies that equipment and systems are installed as per specifications. Operational Qualification (OQ): Ensures equipment operates within defined parameters. Performance Qualification (PQ): Confirms equipment consistently performs under routine conditions using real products or simulations. Change Control and Deviation Management Evaluates and approves change controls related to equipment or facility qualification. Investigates and approves resolution for deviations arising during qualification. Ensures CAPA (Corrective and Preventive Actions) are effective and documented. Material and Component Qualification : Ensures that raw materials, primary packaging materials (vials, stoppers, syringes), and excipients are qualified and sourced from approved suppliers. Environmental and Utility Qualification Oversees the qualification of: HVAC systems Cleanrooms (classified areas) Water systems (WFI, PW) Compressed gases Ensures compliance with microbiological and particulate limits. Sterility Assurance QA is heavily involved in qualifying systems that ensure sterility: Sterilizers (autoclaves, dry heat ovens) Aseptic filling lines Depyrogenation tunnels Isolators and RABS Data Integrity and Traceability Ensures that qualification activities are well documented. Verifies compliance with data integrity standards (e.g., ALCOA+ principles). Ensures audit trails for electronic systems. Requalification and Periodic Review QA defines and approves the requalification frequency. Monitors ongoing performance trends to determine if requalification is needed. Final Release/Approval QA provides the final sign-off for qualified systems or equipment before they are released for GMP use. Ensures all required documentation is complete, accurate, and archived. Interested candidates are can apply on Darpana: 9978604075 OR can email me on darpana@upman.in

We are looking for a skilled Kneat CSV Professional with 6-12 years of experience to join our team at IDESLABS PRIVATE LIMITED. The ideal candidate will have a strong background in Recruitment / Staffing and excellent skills in Kneat CSV. Roles and Responsibility Manage and implement Kneat CSV solutions for clients. Collaborate with cross-functional teams to identify and prioritize project requirements. Develop and maintain technical documentation for Kneat CSV projects. Provide training and support to clients on Kneat CSV tools and features. Troubleshoot and resolve issues related to Kneat CSV implementation. Analyze and optimize client data processing workflows using Kneat CSV. Job Requirements Strong knowledge of Kneat CSV principles and practices. Experience working with large datasets and complex data processing systems. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Strong problem-solving and analytical skills. Familiarity with industry-standard data integration tools and technologies.

Role & responsibilities 1. To maintain the technical details of all manufacturing sites. 2. Review of received URS from site for new procurment/Equipment. 3. Global review of URS requirement,technology and software for harmonization 4. Review of proposal as & when required. 5. Co-ordination with plant & HO. 6. Knowledge of quality assurance & documentation.

The Project Engineer will be responsible for the preparation, review, and management of essential project documentation including User Requirement Specifications (URS), Piping and Instrumentation Diagrams (P&ID), Qualification documents (DO, 1Q, OQ), Gantt charts, and relevant QMS documentation. This role will work closely with the cross-functional teams to ensure alignment with GMP and regulatory standards from the early design phase through to final qualification. In addition to documentation, the role will require hands-on coordination with vendors and contractors for timely execution of site works. This includes floating enquiries, obtaining and reviewing technical and commercial offers, supporting procurement processes, and overseeing material receipts. The Project Engineer will also be involved in day-to-day follow-up with external agencies, supervision of ongoing work, verification of completed activities through measurements, and assisting in preparing documentation for billing and approvals. support vendor evaluation, maintain detailed execution records, and ensure that all engineering deliverables are in line with project timelines, safety standards, and quality expectations.

Role & responsibilities Ensure all Raw Material, Chemical and Packing Material received are tested and released as per the SOP Analyze and approve, if rejected create the discrepancy note, send a copy to Stores and Purchase Dept. and reject the material in SAP Ensure compliance of quality plan is maintained for all in-process stages To initiate corrective actions request for all non-conforming material at incoming inspection, in-process inspection and FG inspection Ensure all equipments and processes are calibrated and validated respectively Ensure Finished Product testing is carried out as per customer and regulatory requirements, review and authorize the Certificate of Analysis To manage, guide and train the QC team Provide support to HOD for MR activities and technical study, internal audits Analyze and release of sterilizing fluid for the production department at the start of production and as and when required Provide Line Clearance in the morning and, as and when required during the whole day Carry In- Process- Quality- Control (IPQC) - To provide support for validation, experimentation, trial of non-methods for in- process improvement. Equipment qualification & Stability studies

Test Lead - Embedded Software Domain: Medical (must have) Location: Bangalore 5 days WFO white field Skill: Experience in qualification of System(computer systems or Analytical instruments). Extensive validation experience in 21 CFR Part 11. Good understanding of GxP standards. Good Knowledge in Data Integrity Well acquainted with all the phases of Validation Life Cycle (VLC). Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications), QRA. Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix and Validation Summary Report (VSR). Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions. Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process. Extensive experience in performing Risk Assessment. Good communication skills and English fluency. Lab equipments knowledge Good to have: Measurement system knowledge Notice Period: 30 Days

Responsibilities: Participate in management review meetings. Review of department trend analysis reports and internal studies or investigations. Ensure corrective action is initiated when required. Provide complete analysis of test results, investigation or information studies. Be capable of assuming study director responsibilities for all routine testing as well as certain advanced or specialized studies as requested by clients. Duties may include test scheduling, test preparation, proper application of test method(s), data collection, data review, and approval of final report of analysis. Maintain thorough knowledge and understanding of all SOPs pertaining to microbiology/sterility assurance. Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the Lan and insure implementation within the department. Maintain thorough knowledge and understanding of regulatory requirements pertaining to microbiology and sterility assurance testing. Play a lead role in the review and approval for appropriate department SOPs, protocols, and data forms. Ensure equipment maintenance and calibration performed within the department meets the calibration/maintenance schedule. Take a lead role in validating new equipment or testing procedures. Regularly attend meetings and seminars to stay current with industry practice. . Required Skills Have good communication skills. Logical Thinking Organizing Required Qualification: - M.sc -Microbiology