253 Oq Jobs - Page 10

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...

Role & responsibilities Utility Executive : 1. Responsible for Operation, Maintenance of Block Utilities & Central Utilities.. 2. Responsible for ordering, maintain stock of spares, consumables required for the machines & facility. 3. Responsible for implementation of Preventive Maintenance activities as per schedule. 4. Execution of Qualification documents. 5. Preparation of SOPs and reviewing of daily log sheets. 6. Responsible for Change Controls & Deviations. 7. Responsible for breakdown analysis &CAPA. 8. Responsible for Energy conservation in Utilities. 9. Responsible for up gradation in utility systems. 10. Responsible for minimising break downs & Improving efficiency of utility syste...

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...

Validation Engineer I What you will do Let’s do this. Let’s change the world. We are seeking an experienced Validation Engineer to work on a GxP platform supporting the Regulatory Submission system and Clinical Trial Registry system. This role will be pivotal in ensuring compliance, efficiency, and innovation in the management of data validation processes. The successful candidate will work on a small team and support continuous improvements and automation within the program. This position combines technical expertise, validation experience, and a strong understanding of regulatory requirements. The role also leverages domain and business process expertise to drive ongoing improvements to va...

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...

Job Summary: We are looking for a motivated Internal Audit Executive (Fresher) to join our Financial Services Internal Audit team in Bangalore. This role provides an excellent opportunity to start your career in internal audit by supporting audit activities, risk assessments, and compliance checks within the financial services sector. Key Responsibilities: Assist in planning and executing audit assignments under the guidance of senior auditors. Support evaluation of internal controls, risk management processes, and compliance with policies. Conduct data analysis and review financial records and operational processes. Document audit findings and assist in preparing audit reports. Work closely...

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 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...

5+ years of overall experience in SAP technology and consulting experience is required. Data integration, data quality, governance, analytics with products like S/4HANA, PaPM, HANA, BPC etc Minimum 2 years of IT experience with SAP PaPM/FS-PER technologies. Strong experience in SAP PaPM/FS-PER with at least end to end Lifecycle implementation. Knowledge about SAP architecture, processes, and data structures Ability to write test cases, perform testing and resolve defects. Location : Pan India

Role & responsibilities The Deputy Manager - CSV will be responsible for overseeing the validation of computerized systems in manufacturing and laboratory environments, ensuring compliance with regulatory standards and best practices. This role requires strong technical knowledge, attention to detail, and effective communication skills to collaborate with various stakeholders. Desired Candidate Profile : The candidate must have a minimum of 5 years of experience in the pharmaceutical industry, with at least 5 years focused on end-to-end Computerized Systems Validation (CSV) for manufacturing and laboratory equipment. Detail-oriented, with primary responsibilities including authoring in-house...

Life Sciences/ Biotech/ Biopharma Validation Specialist Responsibilities: Ensures validation is executed as per the validation plan and/or system change request, and accuracy and quality of data for Q&R fields is maintained in the application inventory management system. Quality Assurance supports, and at times guides, the Business Process Owner, Business Process Expert, and IT team members who are executing the validation activities. Promote high, positive engagement from stakeholders with the process and team. Actively share knowledge and help solve problems with systemic issues driving positive, compliant impact, coaching/mentoring teams as well as assisting in problem-solving for systemi...

Is catcher of PDLM subprojects from Product Industrialization Engineer for a specific technology To follow the good manufacturing practices (GMP) . comprehension of DMR translation to production processes. Provides input for Manufacturing requirements in PDLM. To guide and perform PV related tests (e.g TMV, IQ, OQ & PQ) on the shop floor. Creates Quality Control Plan and Work Instructions Oversees equipment installation and supports rampup of specific processes at the site Gives input from factory side to the sign-off at SR milestone & project close Implements LCM design changes. Identifies and executes improvements in manufacturing processes, tools and equipment. This for quality and effici...

Job Location: Ahmedabad Experience Year : 3-5 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 a 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),...

Your Role Seeking a highly skilled and analytical Biovia d Developer with hands-on experience in BIOVIA ONE Lab , Pipeline Pilot , and ERP-LIMS integration . The ideal candidate will play a key role in designing, developing, and optimizing digital workflows for laboratory operations, ensuring seamless data processing and alignment with business and IT systems. Key Responsibilities: Develop and configure methods and workflows in BIOVIA ONE Lab to support digital lab operations. Design and implement data pipelines using Pipeline Pilot for scientific data processing and integration. Collaborate with IT and lab teams to integrate ERP and LIMS systems with BIOVIA platforms. Analyze business requi...

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...

Hiring manager and Recruiter should collaborate to create the relevant verbiage. Your Role and Responsibilities Work with Development, Product Management, Security, Support, Legal, Customer Success, and other partners to complete Release Management tasks for software products Coordinate with development and stakeholders to set and manage scope, and to prioritize and schedule release activities Develop release plans, timelines, and milestones, and drive the team to finish tasks on time with high quality Facilitate communication to ensure smooth collaboration across different teams Help fix problemsUnderstand the context, get people talking, get to the bottom of it, get action plans and target...