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- Current Projects | NUSANTARA PRIME CONSULTING
CURRENT PROJECTS 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.
- Home | NUSANTARA PRIME CONSULTING
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
- Quality Validation Specialist | NUSANTARA PRIME CONS
Quality Validation Specialist Responsibilities: Provide Quality oversight to equipment/system qualification, automation qualification (PCS/BAS) and cleaning validation Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities Participate in site Validation Maintenance Program Any other tasks as and when assigned by supervisor Support other technical changes and duties as require About You: Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science At least 5 years qualification/validation experience Possess process automation experience will be the additional benefit to be considered Communicate well, self driven, motivated and able to work well with others Based in Tuas Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Problem-Solving and Decision-Making | NUSANTARA PRIME CONS
4 Key Aspects to Problem-Solving and Decision-Making Assessing the SITUATION Identify the concerns Setting priorities Develop an action and resource plan Describe the problem Identify and evaluate possible cause Confirming the root cause Analyzing the PROBLEM DECISION-MAKING Clear Objective Identify options Assess risks Resolution Identify potential problems Identify probable causes Identify countermeasures Prepare and set triggers for contingency action Prepare CONTINGENCY plan Roger Ho | Head of Product Management and Training Services
- Manufacturing Engineer | NUSANTARA PRIME CONS
Manufacturing Specialist Responsibilities: Monitor, optimize, and troubleshoot issues related to either fermentation/cell culture or protein purification processes and unit operations. Perform product quality impact assessments and support root cause assessments for process discrepancies and Quality investigations. Identify and implement corrective actions, preventative actions and continuous improvements for process and equipment. Create, review and revise cGMP documents such as batch records, SOPs, etc. Create change records. Perform gap and technical assessments for global standards and procedures (GSPs and SOPs). Serve as risk lead or subject matter expert in support of risk assessments and hazards analysis e.g. microbial control risk assessments. Develop technical training material and conduct technical training for production staff. Support the technology transfer of new products/processes e.g. perform field testing. Create, review, revise and approve technical reports and engineering documents such as URS, FS, SDS, P&IDs, etc. Design, procure, commission, and qualify new equipment. Work effectively as part of a team responsible for ensuring successful and efficient processes for the production of recombinant proteins. Serve as subject matter expert for regulatory inspections as well as internal audits and support inspection response. Serve as RSTO representative in global network teams such as UOTs and task forces. Experience in Downstream operations for Drug Substance Manufacturing Operations will be an advantage Collaborate with multidisciplinary teams to achieve project objectives. Assist in experimental design and troubleshooting as needed. About You: Min. 5 years of experience Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry). Previous experience in a GMP environment is preferred. Strong attention to detail, organizational skills, and the ability to work independently or in a team. Excellent communication skills, both written and verbal, in English. Adherence to safety protocols and regulatory compliance. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Process Engineer (Active Ingredient) | NUSANTARA PRIME CONS
Process Engineer (Active Pharmaceutical Ingredient) Responsibilities: Responsible for manufacturing process technical support and improvement initiatives for ongoing operations Support start-up and assist in plant equipment and facility validation and qualification activities Supports manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site Supports operational efficiency goals for yield, product quality and other product and/or site KPI’s Contact and consultant for process/equipment troubleshooting and investigation activities Supports risk assessment activities providing relevant technical knowledge Provides support for process cleaning/changeover strategies Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation About You: Chemical Engineering with >5 years of experience in the area of API Manufacturing (Process Engineer) or Manufacturing, Science and Technology (MSAT) role Responsible for manufacturing support of commercial API processes for small chemical molecules Provides rapid response to operational issues and supports ongoing operations including new product introduction, process engineer, process flow diagrams and process batch record authoring Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Warehouse/Logistics Assistant | NUSANTARA PRIME CONS
Warehouse/Logistics Assistant Responsibilities: Ensure accurate and timely receiving and issuance of materials to production from internal warehouse and 3PL to ensure no production stoppages. Raising of materials damage report, materials disposition authorization and any other document to track the movement of inventories Ensure all transfer order transaction in SAP system are completed accurately as per physical movement Support and assist in investigation for any inventory discrepancies, violation of GMP and EHS procedure Responsible for raw materials sampling for laboratory testing according to standard. Involve in routine cycle counting activities which may include physical counting, count check, count verify and data entry of count tabulation. Ensure all inventories are properly managed. Ensure all documentation is handled, filed properly and data are posted accurately in the SAP system. Support for all outbound land, sea and air shipments. Ensure shipments are pack and stuff on time for delivery. Operate all material handling equipment such as forklift and VNA with standard operating and safety procedure. Maintains all material handling equipment and vehicles in good working condition by ensuring preventive maintenance is performed timely. Maintains safe and clean work environment by keeping shelves, pallet area, and workstations neat. Experience in handling sterile and hazardous material Contribute in establishing warehouse SOP (Standard operating procedure) Any other duties assigned by the Superior. About You: Diploma in Supply Chain, ITE or an equivalent Minimum 1-3 years of relevant experience in GMP warehouse environment. Knowledge in GMP (Good documentation practices, sampling) is a must. Able to perform sampling of raw materials (solid and liquid) Able to adapt to changing work schedules and hours including overtime when required Ability to work in a fast pace and challenging environment A willing and engaging team player, contributing positively the team efficiency. Possess a valid forklift license will be an advantage. Able to operate stacker and VNA Prior experience working with SAP system is preferred Based in Tuas. Transport provided Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Laboratory Analyst (Pharma/Biotech) | NUSANTARA PRIME CONS
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.
- EHS Engineer | NUSANTARA PRIME CONS
EHS Engineer (F&B Alternative Food Technology) Responsibilities: EHS Area: To conduct safety briefing to new employee/ contractors/ vendor/ Visitors To conduct regular safety talks to each shift team Support development and implementation of EHS policies To Promote safety initiatives and enhance safety culture in Singapore Operations Conduct risk assessment, job hazard analysis etc and enforce safe management measures. Perform ongoing inspection and safe management measures to identify non-conformity (e.g. not using protective equipment) Coordinate audit related matters and maintain safety documentations. Facilitate and carry out monthly EHS Committee meetings Maintain compliance and updates on new WSH regulations. To collect data the support EHS or Sustainability monthly report/ project etc Continue enhance on current EHS or Sustainability guidelines for SG Operations Coordinate Permit to Work System for plant operations and ensure contractors are fully inducted onto sites and comply with standards Oversee workplace repair, installations and any other work that could have potential risk to safety Verifies that all tools and equipment are adequate and safe for use. Register and investigate WSH incidents and provide statistical information. Conduct safety briefings and trainings according to plans or as and when required Carry out drills and exercises on emergency management. Arrange for OSHA mandated testing and/or evaluations of the workplace by external agencies/consultants. Other duties as assigned Security Area: Incharge of the proxy click system and ensure all visitors are registered. Work closely with area owners to investigate and act immediately on all disciplinary offences. Facility Area: To coordinate with the landlord (YHS) and all other contractors/ vendors as required to properly maintain and manage the local facilities at L10 manufacturing and L2 office area. To conduct routine checks and supervise minor repairs/ replacement works with contractors as part of the safety act. To work closely with L10 and L2 area owner regarding facility maintenance work About You: Degree/ Diploma in Engineering or related equivalent Minimum 1-2 years of relevant experience in SHE management or similar Strong understanding on local legislations and procedures related to SHE Very good understanding of the SHE system Demonstrable following experiences: Experience with establishing SHE policy & procedure Excellent knowledge of potentially hazardous material and practices Hazard and risk management Emergency preparedness Experience in performance analysis, reporting and investigation Behavioural auditing Proficient in MS office application Enjoy problem solving, analytical and a good team player Strong communication skills, organized and good interpersonal skills Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Articles (White Paper) | NUSANTARA PRIME CONSULTING
Root Cause Analysis Tools Ishikawa Fishbone Diagram The model introduced by Ishikawa (also known as the fishbone diagram) is considered one of the most robust methods for conducting root cause analysis. This model uses the assessment of the 6Ms as a methodology for identifying the true or most probable root cause to determine corrective and preventive actions. Five Why's This model uses the 5 Why by asking why 5 times to find the root cause of the problem. It generally takes five iterations of the questioning process to arrive at the root cause of the problem and that's why this model got its name as 5 Whys. But it is perfectly fine for a facilitator to ask less or more questions depending on the needs Failure Mode and Effects Analysis (FMEA) FMEA is a technique used to identify process and product problems before they occur. It focused on how and when a system will fail. Pareto Chart The Pareto Chart is a series of bars whose heights reflect the frequency or impact of problems. On the Chart, bars are arranged in descending order of height from left to right, which means the categories represented by the tall bars on the left are relatively more frequent than those on the right. Scatter Diagram A scatter diagram also known as a scatter plot is a graph in which the values of two variables are plotted along two axes, the pattern of the resulting points revealing any correlation present. Affinity Diagram Also known as KJ Diagram, this model is used to represent the structure of big and complex factors that impact a problem or a situation. It divides these factors into small classifications according to their similarity to assist in identifying the major causes of the problem Fault Tree Analysis (FTA) The Fault Tree Analysis uses Boolean logic to arrive at the cause of a problem. It begins with a defined problem and works backward to identify what factors contributed to the problem using a graphical representation called the Fault Tree. It takes a top-down approach starting with the problem and evaluating the factors that caused the problem. Managers' Talk "Deviations are measured differences between observed value and expected or normal value for a process or product condition, or any departure from a documented standard or procedure. From the agency's perspective, any deviation should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented. Deviation investigation (root cause analysis) aims to determine the root cause of the problem and to provide adequate correction and preventive actions. There are different tools to be utilized in deviation investigations, such as 5Whys analysis and fishbone diagram. Depending on the deviation and rigor, different tools can be used in a RCA. " Kek Xing Yi | Head of Technical Validation

