213 Pq Jobs - Page 9

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...

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 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),...

Job Characteristics: Writes code that meets project requirements and complies with documentation and design standards. Writes the standard documentation used to translate project needs into software design specifications. Corrects defects found through QA software testing and systems testing. Assists in requirements gathering and product definition activities as projects start, and supports field test personnel after development. Assists in creating overall architecture for various software systems. Occasionally provides direction to testing and lab support personnel. Activities contribute to reliable code, documentation and support. Education/Work Experience: Typically requires a degree and...

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...

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...

Experience: 2+ years I Industry/ Domain: Fund Administration Apex Group Ltd has an immediate requirement for a FIS Investran Techno-Functional Senior Associate for its Fund Services business within the Private Equity & Real Estate Funds (PERE) division. The principal responsibilities for the job are managing client reporting request, monitoring the Investran database, enhancing the technical product and supporting operational excellence. . The role requires. Design, develop and implement high quality reports for our global Private Equity clients and their investors. Knowledge of PE GL Suite FIS Investran is a must. Promote product knowledge and team initiatives key PE forums such as the Inve...