211 Pq Jobs - Page 8

Job Location: Ahmedabad Experience Year : 3+ Years Qualification: Bachelors Position: QA-CSV Job Type: WFO Company Name: GSC Technolabs. A Group of GSC Technologies Ltd. Key Job Responsibilities for a QA-CSV Role: Validation Planning: Develop and maintain Validation Master Plans (VMP). Define validation strategy based on risk and regulatory impact. Documentation: Create and review validation documentation including: User Requirements Specifications (URS) Functional Specifications (FS) Design Specifications (DS) Validation Protocols (IQ, OQ, PQ) Traceability Matrix Final Validation Reports Testing & Execution: Lead or perform Installation Qualification (IQ), Operational Qualification (OQ), an...

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP FI S/4HANA Accounting Good to have skills : NAMinimum 7.5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :Person must be having good experience on SAP FI. Must be having good experience on CR, Writing FS etc.As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application requirements are met, overseeing...

Role & responsibilities Review design of new HVAC & BMS (Building Maintenance System) with Utilities team Ensure project execution as per P&G approved design. Provide design improvement ideas for Utilities to enable energy and water saving ideas. Suggest technical improvements in Utility equipments working in Operations and Engineering team. Support detailed design reviews ensuring proposed solutions meet P&G technical standards. Work with site resources to execute the projects. Prepare BOM for HVAC System, compressor system and water treatment system. Assess BOQ supplied by designer and get corrections done. Daily monitoring of project execution work as Utilities SPOC. Get validation done a...

Role & responsibilities Review design of new HVAC & BMS (Building Maintenance System) with Utilities team Ensure project execution as per P&G approved design. Provide design improvement ideas for Utilities to enable energy and water saving ideas. Suggest technical improvements in Utility equipments working in Operations and Engineering team. Support detailed design reviews ensuring proposed solutions meet P&G technical standards. Work with site resources to execute the projects. Prepare BOM for HVAC System, compressor system and water treatment system. Assess BOQ supplied by designer and get corrections done. Daily monitoring of project execution work as Utilities SPOC. Get validation done a...

Must Have: Experience in handling Clients and Stakeholder interactions. Well versed with CSV and GxP process and ability to adopt to client Process, systems and documentation needs like Test Protocol, Test Plan, Test Strategy, IQ/OQ/PQ scripts, RTM, Test Summary Report etc., Understanding of various SDLC methodologies(Agile, Waterfall, V) Flexibility to Work as per Customer timings Generate Automation Test Strategy for applications deployed on Cloud. ( Public and Private cloud) Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. Working experience in testing Restful Webservices and APIs using frameworks or tools like POSTMAN, Rest A...

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...

We are looking for a detail-oriented and proactive Tender Executive with 1–2 years of experience in handling tender processes. The ideal candidate will be responsible for identifying tender opportunities, preparing documentation, coordinating Required Candidate profile • Coordinate with internal departments (Sales, Finance, Technical) • Maintain proper documentation and records of all tender activities. • Strong knowledge of e-tendering platforms (e.g., GeM, CPPP).

Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to align with the o...

Hi, Wishes from GSN!!! Pleasure connecting with you!!! We been into Corporate Search Services for Identifying & Bringing in Stellar Talented Professionals for our reputed IT / Non-IT clients in India. We have been successfully providing results to various potential needs of our clients for the last 20 years. At present, one of our MNC client is hiring Computer System Validation Engineers. PFB the details for your better understanding : 1. WORK LOCATION : CHENNAI 2. Job Role: Engineer / Senior Engineer / Lead 3. EXPERIENCE : 7 to 12 yrs 4. CTC Range: Rs. 15 to 25 LPA 5. Work Type : WFO ****** Looking for SHORT JOINERS ****** Job Description : Min 4+ years of relevant EXP in COMPUTER SYSTEM VA...

Role & responsibilities Minimum 7 years of experience in software testing/validation in a regulated environment. Ability to successfully manage multiple tasks and timelines Ability to effectively liaise with project team members and other teams/departments, on-site and remotely. Ability to perform and coordinate activities required to bring/maintain systems to a validated state. In depth knowledge of Software Development Life Cycle and its major phases Proven experience with testing and validation deliverables such as Test/Validation Plan, Test Script Preparation/Execution/Review, Defect Management, Traceability matrix, Validation Summary Report is required Proven experience in different typ...

About The Role Role: The purpose of the role is to provide assurance on the quality of deployment for the assigned accounts and support in establishing mechanisms that enhance and sustain customer satisfaction levels. The role is expected to support in enhancing customer advocacy by predicting and preventing customer escalations & dissatisfactions and drive a culture of continuous improvement in the assigned accounts. ? Do: Implement deployment quality strategy for the assigned Accounts Provide inputs in the development of strategy for the assigned accounts while considering the quality standards, client expectations, quality, and monitoring mechanisms Review and reallocate the priorities to...

Job Summary We are looking for a detail-oriented engineering team member to coordinate preventive maintenance schedules, manage breakdown records, and ensure adherence to SOPs, critical for maintaining operational efficiency and equipment reliability. This role plays a pivotal part in inventory control, and CAPA closure, contributing to seamless production operations, compliance with regulatory standards, and effective resource utilization. Roles & Responsibilities • To maintain the facility as per cGMP, and GMP requirements of country where product is being exported and strict adherence of Good Engineering practices during task execution. Can handle Water system operation and maintenance. C...

Job Description Must Have: Experience in handling Clients and Stakeholder interactions. Well versed with CSV and GxP process and ability to adopt to client Process, systems and documentation needs like Test Protocol, Test Plan, Test Strategy, IQ/OQ/PQ scripts, RTM, Test Summary Report etc., Understanding of various SDLC methodologies(Agile, Waterfall, V) Flexibility to Work as per Customer timings Generate Automation Test Strategy for applications deployed on Cloud. ( Public and Private cloud) Automate scripts using a given Selenium-based framework, Serenity based BDD framework or any open-source tools. Working experience in testing Restful Webservices and APIs using frameworks or tools like...

Candidates experience with ISO 15378/GMP, ISO 13485, and IQ, OQ, and PQ, particularly in relation to the pharmaceutical industry. Position :- Quality Assurance- Engineer- No of positions:- 1 Location:- Isnapur- Hyderabad Preferred candidate profile

Qualification : Bachelor's degree in a related field or equivalent work experience. Years of experience : 1 to 4 Years relevant experience Required skills : Proven experience in technical document control or a related field. Strong knowledge of document management software and tools. Attention to detail and the ability to work with complex technical documents. Familiarity with project management Familiarity with industry standards and regulations related to documentation. Roles & Responsibilities Manage and control all technical documents, including engineering drawings, manuals, specifications, and procedures Ensure that all technical documentation adheres to regulatory and quality standard...

What you will do Role Description: The Sr. Validation Engineer – Clinical Computation Platform will support the validation and operational management of clinical computation platforms at Amgen, ensuring the integrity and compliance of critical systems and data. This role involves collaboration with various Amgen teams to enhance and secure clinical operations This role involves working closely with developers and business analysts to ensure that the technical requirements for upcoming development are thoroughly elaborated. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance o...

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...

About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle. Learn more about working for ValGenesis, the de facto standard for paperless validation in Life Sciences: https://www.youtube.com/watch?v=tASq7Ld0JsQ About the Role: ValGenesis is the market leader in end-to-end digital validation and we are looking for a Lead Validation Engineer to join our team in Chennai. In this role you will drive the validation processes of...

Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to go further in our efforts to build a more equitable, inclusive world for our employees, our customers and our communities. The Role Are you passionate about delivering exceptional service and revolutionizing the world of technology? We have an incredible opportunity for a talented individual to join our dynamic team as a Plant IT Operations Lead. In this customer-centric role, you will play a pivotal role in ensuring our customers receive top-notch service within a contract...

Computer System Validation Role Currently, we are urgently looking for junior/ mid-senior Labs System CSV / Validation professional for an opportunity in our consulting organization. Desired Skills and Experience A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs. Experience of QA in a FDA regulated environment is preferred. At least 2 years of Computer System Validation or any validation experience required. Experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, su...

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...

Hiring Mechanical Lab Engineer: Perform product testing, sample prep, equipment setup, calibration, maintenance, data analysis & ensure SOP, safety & quality standards. Apply now!

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...

Responsibilities and Duties Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP. Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side. Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5. Coordinate with Client to carry out Validation activity of Computer...

We are seeking a detail-oriented and deadline-driven Tender Executive to manage the complete tendering life-cycle for government and institutional business. You will identify relevant opportunities on various e-procurement portals, coordinate internal documentation, and ensure zero-defect, on-time bid submissions that maximize win probability for our pharmaceutical finished-dosage portfolio. Role & responsibilities The role would encompass a variety of responsibilities, including and not necessarily limited to the following points: Tender identification & tracking: Monitor GEM, CPPP, state e-tender sites, and hospital bulletins daily; circulate opportunity digests and bid/no-bid recommendati...