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  • Contact | NUSANTARA PRIME CONSULTING

    CONTACT OUR OFFICES SINGAPORE OFFICE: NUSANTARA PRIME CONSULTING (NPC) 12 Arumugam Road, #06-04, LTC Building B Singapore 409958 hello@nusaprime.com INDONESIA OFFICE: PT ATUI (PT ANTERO TEKNIK UNGGUL INDONESIA) CYBER 2 TOWER, 18TH Floor JL H.R. Rasuna Said Blok X-5, Kav 13 Kuningan Timur, Setiabudi Jakarta Selatan – DKI Jakarta hello@ptatui.com Thanks for submitting! Submit If you're interested to be part of the team, please submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted

  • Associate Validation Engineer | NUSANTARA PRIME CONS

    Associate Validation Engineer Responsibilities: Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. Manage qualification execution and lead validation deviation investigation encountered in qualification. Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities Participate in site Validation Maintenance Program. Write execution related deviations and change requests. Support change implementation on site. Any other task as assigned by Supervisor/Manager About You: Diploma / Bachelor Degree in Engineering / Science or related Pharmaceutical courses. Min. 2 years' experience in Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, Cleaning validation and temperature mapping is preferred. Fresh Graduates welcome to apply. 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.

  • About Us (WIP) | NUSANTARA PRIME CONS

    OUR STORY OUR STORY NUSANTARA PRIME CONSULTING was founded in 2019 with a single purpose to be the most successful and ground-breaking consulting agency; providing best-in-class services to support our customers in producing quality healthcare timely and economically . We're committed to providing companies and individuals with quality products and innovations in an industry that is constantly changing. The birth of the NUSANTARA brand: NUSA meaning “island ”, and ANTARA meaning “interconnection ” With a holistic thought process, we are dedicated to partnering with our clients on end to end solution support delivering life-saving therapeutic drugs to the patients OUR VISION To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically. OUR MISSION With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients. Meet Our Management! Our dedicated team of consultants is ready to help you develop strategies for not only surviving, but thriving in the future. Simplify your workflow by incorporating the best industry practices and knowledge, enable technology transfer with us. NPCorner ISPE 2023 NPC collaborated with CoBetter to give product awareness on filtration and single use products in ISPE Singapore Affliate Conference & Exhibition 2023. Find out more NPCyclopedia Find out more

  • Associate CSV Engineer | NUSANTARA PRIME CONS

    Associate 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. Responsible for preparation of CSV documents and protocols, perform execution for automated equipment and/or control systems, and closure of executed protocols. Perform troubleshooting during test execution. Responsible for execution of thermal mapping activities. Write execution related deviations and change requests. Any other task as assigned by Supervisor/Manager. About You: Diploma / Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls. Min. 1 year' experiences in CSV preferably in biotech facility. Fresh graduates welcome to apply. Good knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP) Familiar with Health Authorities standards (e.g., FDA CFR and EU) Knowledge of thermal mapping validation and usage of data logger is a plus. Demonstrated proficiency of writte n and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams Must be team player, curious with strong analytical and organizational skills Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • Sale Executive | NUSANTARA PRIME CONS

    Sales Executive (Bioprocess/Life Sciences) Responsibilities: Maximize sales growth in specified geographical territories, consistent with the company strategy and objectives Responsible for Sales Planning and Forecasting activities to support the business Identify leads and market potential to expand customer base, through exploration of the market Responsible to develop new accounts to expand existing business for the portfolio of products and technology Evaluate new opportunities in researching market size and potential of tie-ups with key accounts Accountable for existing and new business activities including and not limited to pricing, contract negotiations, tender submissions, technical support and coordination Drive and realization of new business plan implementation and potential key accounts Plan and execute sales and marketing activities to achieve annual sales target, market share and marketing goals in assigned territories Conduct regular sales and marketing activities Be the key contact point of customer for sales, services, technical support request. Maintain sales record Provide end-user-oriented introduction, organize application and training activities Follow-up to customers Coordinate customer complaints in a timely and organized manner Gather market information and generate sales reports Prepare monthly/quarterly sales performance report. Monitor monthly performance against set targets, and ensure timely/accurate reporting for immediate actions in case of deviations Work closely with internal and external stakeholders to ensure customer expectation/requirements are met Maintain high customer satisfaction ratings Any other projects to be assigned About You: Minimum Diploma or Bachelor's Degree & above in related Science/Engineering fields Minimum 1-2 years working experience in related sales environment in products and services such as Bioprocess, System technology, Life Sciences or lab Consumables, Instrumentation is preferred Good understanding of Pharma/Bioprocessing Market and related procedures is desirable Prior work experience in utilisation of funnel and forecast tools is desirable Self-motivated and independent with ability to work in a matrix –reporting, diverse working environment Good verbal, written communication and presentation skills. A team player with good interpersonal skills Ability to build relationships with key opinion leaders and representatives in the territory and in the specialty segment. Occasional travel (10-20%) might be required Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • What's On | NUSANTARA PRIME CONSULTING

    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.

  • QA TPM Specialist | NUSANTARA PRIME CONS

    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 | NUSANTARA PRIME CONS

    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 | NUSANTARA PRIME CONS

    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.

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