223 Equipment Qualification Jobs - Page 9

Role & responsibilities 1. Preparation of Qualification documents for Pharmaceutical OSD Process Equipments. - URS, DQ, IQ, OQ, PQ 2. Execution of IQ, OQ & PQ of Process Equipments 3. Execution of modification projects 4. Review of Process Equipments layouts & associated utilities 5. Review of Process Equipment Vendor PFDs & PIDs 6. Preparation of URS for Process Equipment’s 7. Preparation of QRA & CR for modification projects 8. Creation of Maintenance plan, Calibration plan for Process equipment’s 9. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 10. Completion of all trainings assigned to role 11. Ensure integrity of data at workplace. 12. Ensure Good Do...

Position: Manager Quality (QMS) Experience: 8 to 14 years Location: Kurla, Mumbai Qualifications: B. Pharma / M. Pharma / M.Sc (Chemistry) Shift Time : 5 PM- Midnight Work Model : Hybrid (3 WFO+ 2 WFH), later can change Industry Preference: OSD and API plant Key Responsibilities & Required Experience: In-depth knowledge of Quality Control investigations including OOS, OOT, Lab Incidents, and Deviations Expertise in Root Cause Analysis and Risk Assessment Hands-on experience with analytical instruments and various QC techniques Proficient in drafting Quality Technical Agreements (QTA) Skilled in compendia assessments , data trending , Annual Product Quality Review (APQR) Exposure to Process V...

Role & responsibilities USFDA Experience Production Equipment Design Knowledge & Trouble shooting methods (Mixing, Filtration, Filling, Sterilizer, Inspection, Packing) FMEA (Equipment Failure Risk Analysis) Technology Transfer from F&D-Equipment. Equipment Qualification(URS,FDS,DQ,FAT,SAT,IQ,OQ,PQ)

Kaliberr bioscience pvt ltd is looking for QA Executive to join our dynamic team and embark on a rewarding career journey You will also be responsible for identifying and resolving quality-related issues and ensuring that the company's products and services meet the requirements of customers Conduct regular quality audits to identify and resolve quality-related issues Develop and maintain quality metrics to track performance and identify areas for improvement Manage the documentation process for quality assurance procedures, including the creation and maintenance of standard operating procedures (SOPs)

Role & responsibilities To perform utility maintenance Equipment qualification Routine & periodic maintenance Preferred candidate profile Experience of pharma background (API / Formulation)

Roles and Responsibilities Ensure compliance with regulatory requirements, company policies, and procedures related to packaging operations. Oversee the entire packaging process from material receipt to product dispatch, ensuring quality control at every stage. Conduct regular audits and inspections to identify areas for improvement and implement corrective actions. Develop and maintain documentation of all packaging activities, including batch records, inventory management, and equipment maintenance schedules. Collaborate with cross-functional teams to resolve issues related to packaging materials, labeling, or productivity. Desired Candidate Profile 9-13 years of experience in pharmaceutic...

Job Description : Business: Pharma Solutions Department: Engineering Location: Digwal Travel: NA Job Overview To maintain the GMP & EHS Documentation related to E&M Key Stakeholders: Internal Production, QA, EHS Key Stakeholders: External Regulatory, Customer Reporting Structure AGM - E&M Positions that report into this role Executive/ Sr. Executive / Dy. Manager Experience 12 years and above Job Description: Responsible for carrying preventive maintenance as per schedule. Should be capable of handling Quality, EHS Audits. Should have in-depth knowledge in cGMP/USFDA Documentation Should have in-depth knowledge in Current safety systems/safe working practices. Person should be capable to Tra...

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 doc...

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 Maste...

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 shoul...

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-fun...

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 ...

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...

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 2...

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 rev...

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...

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 Require...

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,...

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, ...

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...

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 assuran...