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- Quality Operation Associate | NUSANTARA PRIME CONS
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.
- Home | NUSANTARA PRIME CONSULTING
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
- 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.
- 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.

