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QA TPM Specialist Responsibilities: Main contact person for the third-party manufacturing and oversee the TPM operation/process. Responsible for implementing and maintaining the effectiveness of the Quality System. Support to ensure that all quality goals are met, and all practices and procedures comply with company policies, GMP principles and applicable regulations for the quality areas. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments. Manage TPM documents, quality agreement, FMEA, ASL and TPM scorecard/KPI. Review, evaluate and approve all major deviations and determine the need for a corrective action. Document the deviation in the Trackwise system and perform product impact analyses. Review, evaluate and approve all TPM change requests for process related, commodity, raw material, SCN, QC and facilities. Initiate global change in the Trackwise system. Provide a constant review on the manufacturing process, equipment and facilities to assure compliance with procedures, specifications, and policies. Write, review and approve annual product report/product quality report. Actively involved in Pre-campaign activities, post-campaign review (Track & trending program) Perform timely lot disposition in the SAP and LRMS/LotSmart system to meet shipment timeline and demands. Prepare CoA, CoC and release package for drug substance. Coordination of regulatory requests, including country submission, dossier review, GMP Renewal Program. About You: Bachelor Degree with at least 5 years' experiences in pharmaceutical or biotech facility preferably familiar with Quality Compliance, QA Third-party manufacturing oversight and/or QA Operations. Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility Relevant QA background from pharma or biotech environment is preferred Familiar with Health Authorities standards (e.g., FDA CFR and EU) Must be team player, meticulous, strong communication, analytical and organizational skills Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Manufacturing Biotechnologist Upstream Responsibilities: Perform routine manufacturing processes and equipment preparation (CIP, PT, SIP, etc.) Support day to day production activities and record data according to Electronic Batch Record (EBR) in compliance with GMP, Environmental, Health and Safety guidelines. Perform equipment and process monitoring Able to communicate with Supervisor/supporting functions for any safety, quality, and process irregularities Troubleshoot and resolve process related issues. Able to perform production area housekeeping (5S, Kanban, etc.) Review documentation of activities as per GDP (Good Documentation Practice) Use sophisticated softwares / programs (LIMS, SAP, DCS, MES, etc.) to collect and evaluate data Responsible for maintaining and meeting training requirements. Any other task as assigned by Supervisor/Manager About You: Degree/Diploma/ITE in chemical engineering, pharmaceutical or biotechnology equivalent Minimum 1-year relevant biotechnologist experience, experienced in GMP and/or Upstream. Fresh graduates are welcome to apply. Basic skills and knowledge in Fermentation Cell culture, Bioreactor processing, Media and Buffer Preparation and downstream processing is an added advantage. Able to do rotating 12-hour shift work Team player that possesses troubleshooting and analytical skills Must be able to carry heavy load of up to 10kgs Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Project/ Process Support Engineer Responsibilities: Lead projects through the design, procurement, installation and commissioning of new equipment or modifications to existing equipment, facilities and engineering assets, in order to meet operational and reliability requirements for existing product and/or new product introduction. Collaborate with internal resources and/or external contractors to plan, schedule and execute capital projects within established timelines and budgets. Ensure equipment and piping design conforms to industrial standards, master specifications, statutory requirements, SHE standards, cGMP compliance and other necessary requirements. Create, review and/or approve cGMP documents such as SOPs, engineering drawings, change orders, etc. and maintain project documentation as necessary. Partner with maintenance and utility teams to ensure maintenance requirements are duly considered in asset design, support updating of maintenance procedures/work instructions and imparting capabilities for asset maintenance. Partner with reliability teams to provide information for setting up maintenance master data, contribute to total asset lifecycle management and support reliability initiatives for all F&E assets. Assist in preparation of capital budget. Support the technology transfer of new products/ processes to the Singapore site as required. Support qualification of new equipment or modifications to existing equipment as required. Support risk assessments, impact assessments and implement CAPA as required. Support in raising Planned event records in Veeva change management system to get GMP impacting project scope approved for execution. Comply with site Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable. Observe all site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately. Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives. About You: Bachelor of Science/Engineering or higher in a scientific or engineering discipline At least 5 years' experience as a design/project engineer/process engineer or related technical discipline in the pharma/biotech industries. Advanced knowledge of engineering concepts, master specifications, equipment validation and qualification, safety principles, quality systems and cGMP requirements.Working knowledge of site finance and procurement policies relating to capital projects. Working knowledge/experience of procedures related to construction, field safety, welding/installation, passivation, polishing and cleaning etc. Experience in working with Veeva planned events change management systems is preferred. Able to develop solutions to complex problems using sound engineering judgment and advanced engineering knowledge. Must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills. Core Competencies: Willingness to embrace change, ability to adapt to rapidly changing circumstances and courage to challenge status quo when necessary with a view on continuous improvement and achieving targets. Goal-oriented, persistent and driven to achieve results. Willing to take accountability for his/her job assignments. Strong aptitude to acquire and apply engineering knowledge and project management skills. Positive attitude towards continuous learning and contributing his/her expertise within and beyond the assigned work area. Works effectively with other colleagues and partners. Ability to foster a good exchange of ideas from working teams and communicate effectively to members of the project team and stakeholders. Think beyond department and functional boundaries. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

2023 ISPE Singapore Affiliate Conference & Exhibition The ISPE Singapore Affiliate Conference & Exhibition is one of the largest and most respected pharmaceutical manufacturing shows in Singapore for pharmaceutical and biomanufacturing professionals. The annual event highlights the best practices and services from manufacturing facility design to finished products. This year, NPC and CoBetter participated in ISPE 2023 to give product awareness on filtration and single-use products from 23rd to 25th August 2023 at Suntec, Singapore. WhatsApp Image 2023-09-05 at 12.01_edited 1/4 NPC x Cobetter at booth #411.

Quality Validation Specialist Responsibilities: Provide Quality oversight to Cleaning, Standardization and Optimization projects. Review and approve acceptance tests/reports in accordance with relevant policies, standards, procedures, and guidelines timely. Review and approve as needed, qualification/validation exceptions, deviation and/or investigations encountered during acceptance test execution representing Quality. Collaborate with multi functions to arrange, plan, and ensure smooth running of the execution activities. Any other tasks as and when assigned by the supervisor. Support other technical changes and duties as required. About You: Bachelor of Science/Engineering or higher in a scientific or engineering discipline Possess minimum 5 years of qualification/validation experience. Must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills. Must be team player, meticulous, strong communication, analytical and organizational skills Knowledge and ensure compliance with cGMP and safety regulations; Liaise with stakeholders to ensure proper implementation Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams 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.

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

Document Control Specialist Responsibilities: Ensure document Accuracy (Doc No, Dwg no, revision, formatting and etc) Assign document numbers for deliverables and non-deliverables Coordinate documentation flow process, delivery & return of documents in a timely manner Maintain an updated Master list and distribution matrix Manage vendor documents as per company’s requirements and maintain an up to date filing list. Coordinate & Maintain records of all requests for drawings, documents, tags, datasheet and etc To provide accuracy of documentation and to minimize error by maintaining an efficient filing system To upkeep and maintain ISO standards filling so as to retrieve information easily To develop proper coordination internally to ensure timely submission To keep track of outstanding transmittals Collate all project documentation & Transfer to archive at project completion About You: The candidate must have at least 3-5 years’ experience in the construction industry document control Must understand document management and numbering etc. Familiar with Microsoft software such as Access, Excel, Outlook, PowerPoint, Project, Visio, Word, etc. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Process Validation Engineer Responsibilities: Support process validation and characterization studies. Develop process validation and process characterization study protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, and completed in a timely manner or in accordance with project timelines. Manage the execution of process validation and characterization studies and associated deviation investigations. Collaborate with cross-functional teams to arrange, plan, and ensure smooth running and execution of the process validation activities. Support relevant process and technical change management and change implementation activities. Support any other tasks as assigned by the supervisor. About You: Bachelor Degree in Engineering, Biotechnology, Science, Industrial Instrumentation and Process controls or related courses At least 5 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in process validation is preferred. Knowledge and ensure compliance with cGMP and safety regulations; Liaise with stakeholders to ensure proper implementation Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.