278 Pq Jobs - Page 3

Working experience in CSV (Computer System Validation) in Life Sciences domain. Good knowledge of GxP regulations and GAMP 5 Guidelines. Must have experience and knowledge of 21 CFR part 11 and EU Annex 11 regulations. Experience in defining the validation strategy, approach, and alignment with customer on QMS. Good knowledge of good Documentation Practices. Experience in authoring of CSV deliverables such as Validation Plan, Test Plan, RTM, Test Summary and Validation Summary Report, GxP Assessments, 21 CFR Part 11 assessments and System Release Notice. Strong understanding of pharmacovigilance, regulations, guidelines for difference geographic location and Validating Safety Systems. Review...

Job Title: Sr.Manager QA IT- CSV Business Unit: Global Quality & Compliance Job Grade G9B Location : Pithampur, Indore (Greenfield) At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.” Job Summary : The QAIT person is r...

As a candidate for the role, you should have knowledge and experience in handling and troubleshooting purification methods at small scale and pilot scale. You should be well versed in various Chromatography techniques such as Ion exchange, Affinity, and HIC, as well as Ultrafiltration TFF (Hollow Fiber/Cassettes). Additionally, familiarity with FPLC, AKTA- Process, and AKTA- Pilot is required. Your key responsibilities will include: - Developing, optimizing, and executing purification methods for bacterial and viral vaccines - Experience in Cell lysis, different chromatography platforms, TFF systems, Filtration units, and other unit operations used in protein purification - Optimizing and de...

Role Overview: The Engineer Quality Assurance (Equipment Qualification) will be responsible for executing and managing qualification activities (IQ/OQ/PQ/FAT/SAT) for biopharmaceutical equipment and systems in alignment with GMP, GEP, and GAMP standards. The incumbent will act as a key liaison between internal teams and customers during Factory and Site Acceptance Tests, ensuring adherence to regulatory, technical, and quality compliance requirements. Main Responsibilities & Tasks: Lead and execute equipment qualification activities including (IQ), (OQ), and (PQ) . Manage PRE-FAT, FAT, and SAT activities in line with approved test protocols and ensure compliance with specifications and docum...

Responsibilities: Ensure GXP compliance through IQ/PQ processes Collaborate with cross-functional teams during EQ activities Manage QA documentation and reporting Food allowance Provident fund Flexi working

Seeking a CSV Engineer to lead validation of LabVantage LIMS 8.7Hamilton integration via Scitara DLX , using Kneat Gx for lifecycle management. Ensure GxP/21 CFR Part 11 compliance, collaborating with QC, QA, IT, and vendors .

What you will do: Support the implementation of process improvements to Corporate/Site/Division Supplier Initiated Change Request procedures and process. Served as owner, execute, and maintain the electronic systems related to SICRs, and support data alignment (SICR Database & OnePLM SICR Library) Challenge suppliers SICRs forms for completeness and accuracy. Discuss corrections to the form to guarantee a smooth assignment and execution of the change. Own & Execute Supplier Initiated change request (SICR) submitted by Global Suppliers Review Submitted SICRs and challenge suppliers for missing information & required deliverables for approving the change Organize SCRB with Key Stakeholders and...

Infiquity Technologies is looking for CAN Validation Engineers to join our dynamic team and embark on a rewarding career journey. A Validation Engineer is responsible for planning, executing, and documenting validation activities to ensure that processes, systems, and products meet specified requirements and comply with regulatory standards. This role involves collaboration with cross - functional teams, adherence to quality protocols, and maintaining compliance with industry regulations. Key Responsibilities : Validation Planning : Develop and implement validation master plans, protocols, and procedures. Define validation strategies based on project requirements and regulatory guidelines. P...

Department Procurement Reports To Head of Supplier Relationship Manager About the team Fidelity Internationals Global Procurement function provides Source to Pay and Third Party Risk Management services to FIL colleagues globally. It comprises approximately 95 colleagues, based across UK, India, Continental Europe, and Asia Pacific, overseeing spend of ~$700m in 26 countries. The existing SRM function is established to ensure alignment and a drive best practice supplier relationship management across all FIL supplier management activity globally. The SRM will be part of a global team covering UK Ireland India, forming a broader community with ~6 colleagues in Gurgaon who will undertake commo...

Greetings! & very warm welcome to BEST-FIT Recruitment Riders, We are BEST-FIT Recruitment Riders feel immense pleasure to search and provide you with better carrier opportunities to aid you in achieving your aspirations. BEST-FIT Recruitment Rider is a highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors. We are searching & recruiting highly qualified professionals for Middle-Senior-Upper-Management and Executive jobs. (Eg: Managers, VP, President, CFO & CEO). Also offering customized recruitment services by Headhunting & Executive Search for Middle & Top manag...

Urgently Required CSV Trainer For Part Time Basis and Online Training Sessions. Should have Experience in Computer system validation and LIMS Functional Specifications (FS)Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) (FDA, EMA, GAMP 5 Required Candidate profile Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Classes Mode Online or Remote Mode Interested Directly Please Contact - 9133469786

Our Digital ambition at Sanofi We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Digital is at the heart of Sanofi: our ambition is to be the leading digital healthcare platform to develop & deliver medicine faster, enable healthcare professionals to improve treatments and help patients improve their health. At Sanofi, were committed to providing the next-gen healthcare that patients and customers need. Its about harnessing data insights and leveraging AI responsibly to search deeper and solve sooner than ever before. About the Job We are looking for an experienced Identity Governance and Administration (IGA) expert wi...

Department Procurement Location Gurgaon, India Reports To Head of Supplier Relationship Manager Level Grade 5 We are proud to have been helping our clients build better financial futures for over 50 years. How have we achieved this? By working together - and supporting each other - all over the world. So, join our team and feel like youre part of something bigger. About the team Fidelity Internationals Global Procurement function provides Source to Pay and Third Party Risk Management services to FIL colleagues globally. It comprises approximately 95 colleagues, based across UK, India, Continental Europe, and Asia Pacific, overseeing spend of ~$700m in 26 countries. The existing SRM function ...

Role Overview: You will be responsible for documentation and execution of qualification activities. This includes preparation, review, and execution of various documents such as URS, DQ, FDS, UTM, IQ, OQ, PQ, RQ, and risk assessments. Your role will involve managing FAT and SAT for new projects, reviewing raw data and test reports, and preparing final summary reports. You will also be responsible for protocols and reports for validation processes, initiating CRNs, implementing CAPAs, and conducting incident investigations. Additionally, you will prepare and review VMP, provide training, update SOPs, and assist in inspections. Key Responsibilities: - Preparation, review, and execution of qual...

As a Document Controller at SEPAM in Chennai, your role involves managing project documentation, records, and communication tasks related to document management. Key Responsibilities: - Hands-on experience in GMP, Equipment Qualification, DQ/IQ/OQ/PQ - Experience in FMCG projects - Proficient in Document Management and Project Documentation - Skilled in Documentation and Records Management - Strong communication skills - Attention to detail and organizational skills - Proficiency in document control software - Ability to work effectively in a team environment Qualifications Required: - Bachelor's degree in a relevant field Note: Additional details about the company are not provided in the jo...

Role & Responsibilities: 1. To review the product manufacturing records, testing records. 2. To monitor the aseptic practices in the shifts like online process checking and documentation. 3. To co-ordinate for in-process sampling and to monitor the EM activities 4. Responsible for ensuring the Validation & Calibration activities. 5. Validation & Qualification protocols preparation, and the implementation 6. Preparation and Review of SOPs. 7. Responsibility of Sterile IPQA operations 8. Handling of the change controls and to ensure the implementation of changes 9. Preparation and Review of the quality risk assessment. 10. Responsible for ensuring the deviations and OOS are investigation and n...

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines, FDA documentation requirements, and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the Quality Control Laboratory to ensure all testing is performed ...

This Position reports to: Senior Project Lead Engineer Your role and responsibilities In this role, you will have the opportunity to support engineering activities in all types of project sizes and complexities, under the supervision of senior engineers. Each day, you will complete the tasks cost-effectively and in accordance with contract specifications, quality standards, safety requirements, and cybersecurity policies and standards. You will also showcase your technical knowledge by collecting data and supporting production of the engineering design. You will be mainly accountable for: Performing survey work, standard computations, analysis, and basic design tasks. Exercising judgment on ...

Responsibilities: Monitor manufacturing and packaging processes, including line clearance and in-process checks (IPQA) Manage documentation activities, including DOC-QMS systems, SOP preparation, deviation handling, and change control Support Technology Transfer (TT) activities by reviewing protocols, executing processes, and coordinating between R&D and manufacturing teams Ensure compliance with 21 CFR Part 11 requirements through validated software systems for electronic records and signatures Execute equipment qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities Utilize automated quality systems and digital platforms for manufacturing documentation Mainta...

Responsibilities: Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process. Ensure all operations comply with GMP guidelines and internal quality standards. Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements. Participate in the review and approval of finished product batch records and assist in product release processes. Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner. Support the quality control laboratory in ensuring that all testing is performed in accordance with regulat...

We are looking for a skilled CSV Lead with 15-25 years of experience to join our team. The ideal candidate will have expertise in ServiceNow and HPALM. Roles and Responsibility Manage and implement CSV solutions using ServiceNow and HPALM. Collaborate with cross-functional teams to ensure seamless integration of CSV with other systems. Develop and maintain documentation for CSV processes and procedures. Troubleshoot and resolve issues related to CSV implementation. Provide training and support to end-users on CSV tools and features. Ensure compliance with industry standards and best practices for CSV management. Job Requirements Strong knowledge of ServiceNow and HPALM. Experience in managin...

Skill: CSV Manager Notice Period: Immediate . Employment Type: Contract Working Mode : Hybrid Job Description 12+ years of experience working in electronic based Computer System Validation in a GxP environment Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process Experience in employing risk-based approaches to CSV Experience in qualification of GLP Instrument Systems Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems Experience in perform

Responsibilities: Identify new business opportunities in the System Integration and Network Engineering services segments ofTelecommunication, IT, ITES, Smart City, FiberGrid, Digital Private Networks, Smart Classroom solution. Identify new business opportunities, EOI and Partnerships by monitoring Indian Government e-Tendering portals, PSU Portals, GeM portals & oversees portals as required. Ensuring all the PQ (Pre-qualification) and TQ (Technical Qualification) Documents are kept ready according to the RFP. Ensure all proposals meet the requirements outlined in the Request for Proposal (RFP), Request for Quotation(RFQ) & EOI (Expression of Interest).

As an experienced candidate with 4-5 years in validation documentation, you will be responsible for preparing Machine DQ, IQ, OQ, PQ, operational manuals, and all supporting documents in accordance with customer requirements. Key Responsibilities: - Minimum 4-5 years of experience in validation documentation - Preparation of Machine DQ, IQ, OQ, PQ, operational manuals, and supporting documents as per customer requirements Qualifications Required: - Relevant experience in validation documentation - Strong attention to detail - Ability to work in compliance with customer requirements The company offers the following benefits: - Cell phone reimbursement - Food provided - Internet reimbursement ...

We are looking for a skilled Process Validation Engineer to join our team in Pune. The ideal candidate will have 3-10 years of experience in process validation and quality systems, with a strong background in regulatory compliance and hands-on experience in manufacturing activities. Roles and Responsibility Perform gap assessments and conduct remediation of documents with stakeholder inputs. Develop and maintain Manufacturing/Service Work Instructions and related documents. Create/modify process flows within the Manufacturing/Service Departments. Support the development and introduction of new products, processes, and technologies, focusing on quality systems. Monitor and drive corrective ac...