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  • Validation Engineer | NUSANTARA PRIME CONS

    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.

  • Privacy Policy | NUSANTARA PRIME CONS

    Privacy Policy Information gathered from visitors Log files are stored on our web server saving details such as visitors' IP address, browser type, referring page and time of visit. Cookies may be used to remember visitor preferences when interacting with the website. Where registration is required, the visitor's email and a username will be stored on the server. How the Information is used The information is used to enhance the vistor's experience when using the website to display personalised content and possibly advertising. E-mail addresses and other information collected by NUSAPRIME.COM will not be sold, rented or leased to 3rd parties. E-mails may be sent to inform you of news of our services or offers by us or our affiliates. Visitor Options If you have subscribed to one of our services, you may unsubscribe by following the instructions which are included in e-mails that you receive. You may be able to block cookies via your browser settings but this may prevent you from access to certain features of the website. Cookies Cookies are small digital signature files that are stored by your web browser that allow your preferences to be recorded when visiting NUSAPRIME.COM . Also, they may be used to track your return visits to the website. 3rd party advertising companies may also use cookies for tracking purposes. Google Ads Google, as a third party vendor, uses cookies to serve ads. Google's use of the DART cookie enables it to serve ads to visitors based on their visit to sites they visit on the Internet. Website visitors may opt out of the use of the DART cookie by visiting the Google ad and content network privacy policy.

  • 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

  • Manufacturing Biotechnologist | NUSANTARA PRIME CONS

    Manufacturing Biotechnologist (Downstream/Central Service) 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/laboratory experience, familiar in GMP and/or Upstream/Downstream/Central Services. Fresh graduate is 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 where applicable. Based in Tuas Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • Our Offerings | NUSANTARA PRIME CONSULTING

    OUR OFFERI NGS Our Specialist Services include focus on Process/Project Engineering and Design, Project Management, Facility expansion and improvement, Technology Transfer, Regulatory affairs, GMP & Audit Training, Commissioning, Qualification, Validation, Quality Assurance & Control, Process Development and Waste Water Treatment Processing consultation with aim of Zero Liquid Discharge (ZLD) for a circular economy to clients in the Biopharmaceuticals, API Pharmaceuticals, Life Sciences and Food & Beverage (F&B) industries in the ASEAN region. Design solution Conceptual, Basic, Detailed Designs projects Construction, Commissioning, Qualification staff augmentation Operation Support, Engineering Support, Quality Control & Assurance technology transfer management With the professional advice of our consultants Validation support Process Validation, Product Validation, Computer System (CSV), Cleaning Validation health authority audit training Technical Training for Staff expansion consulting Facility/Production Line Expansion, Improvement Support and Consulting, Process and Facility Debottlenecking Study MES EBR Setup, Planning, Implementation and Validation TEchnology support Product Supports and Digitalization waste management consulting ZLD = Zero Liquid Discharge product management ZLD = Zero Liquid Discharge Meet Our Clients YOUR GOALS IS OUR MISSION Begin your planning, with a consultation with us! Submit Thanks for submitting!

  • HR & Admin Assistant | NUSANTARA PRIME CONS

    HR & Admin Assistant Responsibilities: Perform daily administrative and assist human resources tasks within the department Assist in recruitment activities including job advertisement posting and downloading of resumes from job portals Assist in the onboarding process for new hires including preparation of Employment Agreement, onboarding document, conduct orientation, employee data input into HR system and etc Assist in the offboarding process for resign staff including preparation of letters, exit interview and exit clearance Monitor and assist in work pass administration for new application, renewal and cancellation Grant submission on Government portal Maintain, update and ensure proper documentation filing for all HR and admin related document and files Provide secretarial support to the CEO Provide office administration support including but not limited to procurement of office and pantry supplies, office equipment maintenance and etc Provide administrative support to the Management and sales team including preparing of sales related document, travel booking and etc Act as the point of contact within company for any administrative or basic HR-related inquiry Assist in scheduling meetings, conference calls, corporate/team functions or organising company events Assist in the preparation or update of company organisation chart, policies and process flows Assist in the preparation of company newsletters and festive greeting poster Assist in ad-hoc HR projects and any other assigned Admin duties About You: Possess Diploma / GCE 'A' Levels Minimum 1 to 2 years of relevant experience in HR or office administration support Have a good sense of urgency, meticulous and demonstrate initiatives with good follow-up skills Working knowledge of local labour legislation Comfortable interacting with people at all levels Able to work independently, multi-task and a good team player Able to work in fast pace environment Proficient in Microsoft office applications is a must Must have a good attitude of motivation Hybrid office and work from home arrangement * Internship/Part-time options available Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • 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.

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