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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-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.

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 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.

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/ Project Engineer Responsibilities: Experience in upstream / downstream / Central services process operation, (experience in equipment design for process equipment will be an advantage). Responsible for basic and detailed design, commissioning and qualification activities, including URS development, FAT, SAT, DQ, IQ, OQ and PQ. Review industry practices for best-in-class approach. Ensure that the appropriate Quality standards are applied consistent with best practice and internal Quality Standards and expectations. Engage with project teams to deliver the project from conceptual through implementation phase, encompassing support for a wide range of engineering and construction requirements. Coordinates with different functions like manufacturing, project engineering team, validation and quality for implementation of changes associated with the project. Work independently and/or with the project manager to complete the engineering projects within schedule, budget and quality constraints. Any other task as assigned by Supervisor/Manager. About You: Diploma/Degree in Chemical Engineering, Chemistry or equivalent with at least 5 years' experience in a process engineering role or similar role with a biologics manufacturing plan At least 2-5 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in Process Engineer In Biologics industry with understanding of cGMP requirement Should have Design experience at various stages of project (Base, Detailed design) Preferably handling the Autoclave, Glove box, CIP Skid during project phase Able to support Installation, Commissioning & Qualification activity at site. Any other task given related to Process. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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.

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.

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.

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