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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

QA CSV Specialist Responsibilities: POC and coordinator for data integrity projects, ensure company’s quality requirements and agencies’ requirements are met. Quality oversight for automation qualifications (Delta V and BAS) and GMP equipment qualifications Review and approve of qualifications- related documentations (protocols and reports) Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements. Review and approve SOPs Review and approve associated deviations Ensure that the appropriate Quality standards are applied consistent with internal Quality Standards and expectations. About You: Bachelor Degree with at least 5 years' experiences in CSV QA validation preferably in biotech facility Knowledge of validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a biotech facility Automation background from biotech environment who wants to venture as CSV QA validation Familiar with Health Authorities standards (e.g. FDA CFR and EU) Must be team player, curious with strong analytical and organizational skills Willing to be placed in Tuas Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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

Senior Manufacturing Engineer Responsibilities: Responsible for handling the development of operation protocols for upstream or downstream operations starting from the dispensary of raw materials up to end of the manufacturing process. Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production Support Change Records Assessment and GMP documentation Review. Responsible for providing support to the assigned manufacturing operations by developing, coordinating, and facilitating small to medium projects to ensure planned, predictable production operations in compliance with GMP regulations. Lead and execute Continuous Process Improvements, CAPAs and Change Records in the assigned area. Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over. Lead project teams to troubleshoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance. Collaborate with multidisciplinary teams to achieve project objectives. Assist in experimental design and troubleshooting as needed. About You: Bachelor's degree in a relevant life science or Engineering field (e.g., biology, biotechnology, biochemistry). At least 5 years of experience in the Manufacturing / 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.Adherence to safety protocols and regulatory compliance. 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? 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 Consulting 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 :hello@ptatui.com : PT Antero Teknik Unggul Indonesia

QA Production Associate Responsibilities: Support the maturation and continuous improvement of site quality systems, including On-the-floor quality oversight, deviation management, change control and ensure that the systems are managed in compliance with cGMP expectations Participate in on the floor triage and support root cause investigations for major investigation if applicable Review and approve minor deviation, change controls, and other quality records such as electronic batch records, SOPs, logbooks and work orders Support in regulatory inspections, and interact directly with regulatory inspectors Supporting other QA initiatives/activities such as continuous improvement projects, supplier quality, stability program, product quality review, customer complaint investigation Escalate any significant event to Quality management in a timely manner About You: Bachelor’s Degree in Science or engineering related 1-4 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility and demonstrated experience in quality assurance, and quality systems. Fresh graduates are welcome to apply. Direct experience with bulk manufacturing of biopharmaceuticals preferred. Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff Fluency in written and spoken English Based in Tuas, able to work predominantly on night shift, 8pm to 8am, on a 2-2-3 shift pattern Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

CQV Lead Responsibilities: Lead a team of engineers in the delivery of commissioning activities/ qualification activities/automation I/O checks on all associated equipment to ensure CQV execution phases progress as per schedule. Review of Commissioning, Qualification Verification (CQV) documentation Loops packs for all associated equipment Field execution and supervision of Loop checking and Calibrations of process, equipment and clean & black utilities Attend regular client meetings to present on progress Co-ordination/review of vendor packages to achieve streamlined CQV Co-ordination/Review of construction packages to achieve streamlined CQV About You: Degree in Engineering or Science and a minimum of 5 years of experience within a Life Sciences environment Relevant experience working on process equipment, Clean utilities and facilities Hands on validation execution experience Experience in leading daily validation meetings with cross functional in resolving validation issues. Experience of working in a project environment Strong stakeholder management skills Excellent oral and written communication skills in English Self starter and able to drive project timeline Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Admin & Marketing Assistant Responsibilities: Perform daily administrative and assist human resources tasks within the department Manage and maintain company's social media account and respond to email enquiries promptly. Assist in preparing marketing related documents for local and overseas customers 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.

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.

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