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QC LEQ Engineer Responsibilities: Responsible for managing and writing of qualification related documentation but not limited to Qualification Plan and IQ, OQ, PQ and ERES Test Scripts for QC laboratory equipment (lab bench and CSV system) Responsible for overseeing execution of but not limited to IQ, OQ, PQ and ERES Test Scripts of QC laboratory equipment (lab bench and CSV system) and test script for new equipment deployments. Manage and maintain the progress tracking matrix on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team. Coordinate and manage deviation to be initiated, assessed and closed out in timely manner. Responsible for stakeholder management including coordination with QC lab team on equipment availability for qualification activity. Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation. Work with IT team to develop the CSPECs, ERES etc to fulfill Part 11 requirement. Responsible for managing computerized system validation lifecycle data integrity portion and risk assessment. Handover and coordination post LEQ execution to QC lab Any other task as assigned by Supervisor/Manager About You: Bachelor in Engineering, Sciences, Business, Information Systems or equivalent. Min 5 years of experience in QC Lab Equipment Qualification in pharma or biotech facility. Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility Good interpersonal, communication and presentation skills. Must be a self-starter, fast learner, curious with strong analytical and organizational skills Self-motivated and willingness to learn Reliable and Responsible Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

OUR OFFERI NGS Our Specialist Services include focus on Process/Project Engineering and Design, Project Management, Facility expansion and improvement, Technology Transfer, Regulatory affairs, GMP & Audit Training, Commissioning, Qualification, Validation, Quality Assurance & Control, Process Development and Waste Water Treatment Processing consultation with aim of Zero Liquid Discharge (ZLD) for a circular economy to clients in the Biopharmaceuticals, API Pharmaceuticals, Life Sciences and Food & Beverage (F&B) industries in the ASEAN region. Design solution Conceptual, Basic, Detailed Designs projects Construction, Commissioning, Qualification staff augmentation Operation Support, Engineering Support, Quality Control & Assurance technology transfer management With the professional advice of our consultants Validation support Process Validation, Product Validation, Computer System (CSV), Cleaning Validation health authority audit training Technical Training for Staff expansion consulting Facility/Production Line Expansion, Improvement Support and Consulting, Process and Facility Debottlenecking Study MES EBR Setup, Planning, Implementation and Validation TEchnology support Product Supports and Digitalization waste management consulting ZLD = Zero Liquid Discharge product management ZLD = Zero Liquid Discharge Meet Our Clients YOUR GOALS IS OUR MISSION Begin your planning, with a consultation with us! Submit Thanks for submitting!

PIONEERING LEAN, HOLISTIC SOLUTIONS FOR PHARMACEUTICAL , LIFE SCIENCES AND F&B INDUSTRIES ACROSS ASIA HOW DO WE DO IT? GET TO KNOW US NUSANTARA PRIME CONSULTING is a Singapore-based company that focuses on technical consulting solutions led by a team of industry practitioners. We have been delivering solutions to clients since 2019 with an impressive portfolio of professional consulting services that are completely customizable for your business. Interested to be part of us? Submit your resume to recruitment@nusaprime.com OUR OFFERING S Whatever your needs may be, we can make it happen. Get in touch with us today. BOOK CONSULTATION Design Solution PRojects staff augmentation technology transfer management validation support health authority audit training expansion consultation waste management consulting mes technology support Contact Us Address Location Singapore Office NUSANTARA PRIME CONSULTING (NPC) ​ 12 Arumugam Road, #06-04, LTC Building B Singapore 409958 Contact Phone Mail : +65 6910-8368 : hello@nusaprime.com : NUSANTARA PRIME CONSULTING PTE LTD (Nusaprime) Location Indonesia Office PT ANTERO TEKNIK UNGGUL INDONESIA (PT ATUI) ​ ​ CYBER 2 TOWER, 18TH Floor JL H.R. Rasuna Said Blok X-5, Kav 13 Kuningan Timur, Setiabudi Jakarta Selatan – DKI Jakarta Mail : rudy.siswanto@ptatui.com : PT Antero Teknik Unggul Indonesia

Quality-Automation Liaison Responsibilities: Initiate Document Tracking once finished draft received from Automation Engineer. Organize and trace document lifecycle, on AttachePro. Liaise with Quality Assurance, Quality Compliance, Computerised System Validation for Automation Documents. Learn manufacturing process and respond to test event deviations, keep track of repetitive responses for re- use and create where required. Support automation projects (Delta V, PLC/SCADA and OSI PI) in accordance with policies and procedures. Obtain approval for system installation, configuration, testing and commissioning documents. Manage Computer System Validation Lifecycle from design to execution phases. Once more experience is gained, ability to evaluate change requests and assist in drafting. Any other task as assigned by Supervisor/Manager. About You: Industrial, Pharmaceutical, Chemical or relevant Engineering degree. Basic knowledge of Automation System Architecture is required, exposure to Emerson DeltaV is a plus but not required, training will be provided. Knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP) Adaptable, proactive, able to build relationship with other professionals. Must be team player, curious with strong analytical and organizational skills. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

PIONEERING LEAN, HOLISTIC SOLUTIONS FOR PHARMACEUTICAL , LIFE SCIENCES AND F&B INDUSTRIES ACROSS ASIA HOW DO WE DO IT? EMBRACE SUSTAINABILITY NUSANTARA PRIME CONSULTING is a Singapore-based company that focuses on technical consulting solutions led by a team of industry practitioners. We have been delivering solutions to clients since 2019 with an impressive portfolio of professional consulting services that are completely customizable for your business. Whatever your needs may be, we can make it happen. Get in touch with us today. Learn More OUR OFFERINGS Discover Our Expertise ENGINEERING DESIGN SOLUTIONS Achieve Your Goals Read More CONTACT OUR OFFICES SINGAPORE OFFICE NUSANTARA PRIME CONSULTING (NPC) 12 Arumug am Road, #06-04, LTC Building B Singapore 409958 admin@nusaprime.com INDONESIA OFFICE: ​ PT ATUI (PT ANTERO TEKNIK UNGGUL INDONESIA) ​ CYBER 2 TOWER, 18TH Floor JL H.R. Rasuna Said Blo k X-5, Kav 13 Kuningan Timur, Setiabudi Jakarta Selatan – DKI Jakarta ​ rudy.siswanto@ptatui.com Thanks for submitting! Submit

Validation Engineer Responsibilities: Support equipment/system qualification and cleaning validation Develop cleaning validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion Manage qualification/validation execution and lead the validation deviation investigations encountered during qualification/validation Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities Support Change Implementation on site Any other tasks as and when assigned by supervisor Support other technical changes and duties as required About You: Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science. At least 4 to 6 years qualification/validation experience. Cleaning validation experiences in Biologics and/API process. Based in Tuas Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

WHAT'S ON NUSANTARA PRIME CONSULTING solves each client’s issues by providing a comprehensive approach backed by our team of experienced professionals. Our process fosters collaboration and innovation to ensure we not only understand the core needs of clients, but also help them develop successfully. Read our success stories below. PERMITTING FOR 70 WIND TURBINES Clients often approach NUSANTARA PRIME CONSULTING with a general idea of what they need, and this project was no different. We were able to jump right in with our expertise and really helped the company grow and evolve. Today, their business is doing exceptionally well, and we’re proud to have been part of the process. SOLAR ENERGY INSTALLATION Often times our clients have everything they need to succeed, they just require the resources and support to make a strategic jump. We worked on this project for several months and the end result was truly spectacular. By ensuring consistent and transparent communication, our client was able to progress by leaps and bounds. AIR POLLUTION CONTROL We approached this project carefully, as it was our very first undertaking of this scale. We studied our client’s business to create a focused and effective solution - and then watched it grow. We loved working with this client, and look forward to collaborating together on many more successful projects in the future.

Validation Engineer Responsibilities: Support equipment/system qualification and cleaning validation Develop validation lifecycle document and protocols/reports in accordance with relevan t policies, standards, procedures and guidelines, and completed in a timely fashio n Manage qualification/validation execution and lead the validation deviation investigation s encountered during qualification/validation Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities Participate in site Validation Maintenance Program Support Change Implementation on site Any other tasks as and when assigned by supervisor Support other technical changes and duties as required About You: Engineering/Science Degree or higher from recognised institution At least 5 years of experience in Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, Cleaning validation and temperature mapping is preferred. Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility Good oral and written communication skills. Meticulous and Systematic Team player, with strong focus on safety, quality and timeline Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Laboratory Analyst (Pharma/Biotech) Responsibilities: Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath, etc. Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management Review lot release data, identify testing discrepancies and participate in laboratory investigations Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness To assist in writing SOP documents, change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design To carry out completion and review of GMP Documentation of data sheets or LIMS software To carry out QC sample receipt, assay and release procedures Support Audit preparation and any audit related activity Reading and understanding the test procedure and the requirements per USP, JP and EP About You: Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree At least 1-3 years relevant experience depending on qualification, preferably in the bio-pharmaceutical / Pharmaceutical industry Good working knowledge of cGMP and regulatory requirements related to Quality is preferred Problem-solving and troubleshooting skills Highly motivated and independent Possess good interpersonal and communication skills Knowledge of cGLP / cGMP, FDA, EMA and ICH guidance and industry standards for analytical development and characterization Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Quality Operation Associate 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.