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  • Testimonial | NUSANTARA PRIME CONSULTING

    MEET OUR CLIENTS We’re fortunate to work with some of the best clients around, and would love for you to become a partner. Our team includes experts from many fields who are ready to help develop and grow your business. From ideation to execution, we have vast experience throughout.

  • CSV Engineer | NUSANTARA PRIME CONS

    CSV Engineer Responsibilities: Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. Work with QA and stakeholders to develop the CSV strategy Responsible for providing CSV documents and protocols, performing execution for automated equipment and/or control systems, and closure of executed protocols. Responsible for test case execution, deviation handling and drafting of system SOPs. Any other task as assigned by Supervisor/Manager. About You: Bachelor of Science/Engineering or higher in a scientific or related engineering discipline At least 4 – 8 years of experience in validation or computerized system validation Able to initiate and drive validation discussion. Must be a team player, curious with strong analytical and organizational skills. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • Quality Operation Specialist | NUSANTARA PRIME CONS

    Quality Operation Specialist Responsibilities: Ensure that products manufactured meet approved company policies, processes and procedures Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities. Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out. Release incoming material, process, and product batches. Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product. Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies. Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times. Participate and support new product introduction, operation excellence projects and other tasks as assigned by management About You: Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics Minimum of 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment. Experience in SAP, Trackwise are preferred Ability to quickly know products and processes in order to assess quality issues Committed to quality and maintain a high standard of work at all times Demonstrates the highest levels of integrity and a strong work ethic Good knowledge of GxP requirements and regulations Good planning and scheduling skills Good communication and interpersonal skills both verbal and written Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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