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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.

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 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 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 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) 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.

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 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.

Sales Executive (Bioprocess/Life Sciences) Responsibilities: Maximize sales growth in specified geographical territories, consistent with the company strategy and objectives Responsible for Sales Planning and Forecasting activities to support the business Identify leads and market potential to expand customer base, through exploration of the market Responsible to develop new accounts to expand existing business for the portfolio of products and technology Evaluate new opportunities in researching market size and potential of tie-ups with key accounts Accountable for existing and new business activities including and not limited to pricing, contract negotiations, tender submissions, technical support and coordination Drive and realization of new business plan implementation and potential key accounts Plan and execute sales and marketing activities to achieve annual sales target, market share and marketing goals in assigned territories Conduct regular sales and marketing activities Be the key contact point of customer for sales, services, technical support request. Maintain sales record Provide end-user-oriented introduction, organize application and training activities Follow-up to customers Coordinate customer complaints in a timely and organized manner Gather market information and generate sales reports Prepare monthly/quarterly sales performance report. Monitor monthly performance against set targets, and ensure timely/accurate reporting for immediate actions in case of deviations Work closely with internal and external stakeholders to ensure customer expectation/requirements are met Maintain high customer satisfaction ratings Any other projects to be assigned About You: Minimum Diploma or Bachelor's Degree & above in related Science/Engineering fields Minimum 1-2 years working experience in related sales environment in products and services such as Bioprocess, System technology, Life Sciences or lab Consumables, Instrumentation is preferred Good understanding of Pharma/Bioprocessing Market and related procedures is desirable Prior work experience in utilisation of funnel and forecast tools is desirable Self-motivated and independent with ability to work in a matrix –reporting, diverse working environment Good verbal, written communication and presentation skills. A team player with good interpersonal skills Ability to build relationships with key opinion leaders and representatives in the territory and in the specialty segment. Occasional travel (10-20%) might be required 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.