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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.

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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 Validation Engineer Responsibilities: Support process validation and characterization studies. Develop process validation and process characterization study protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, and completed in a timely manner or in accordance with project timelines. Manage the execution of process validation and characterization studies and associated deviation investigations. Collaborate with cross-functional teams to arrange, plan, and ensure smooth running and execution of the process validation activities. Support relevant process and technical change management and change implementation activities. Support any other tasks as assigned by the supervisor. About You: Bachelor Degree in Engineering, Biotechnology, Science, Industrial Instrumentation and Process controls or related courses At least 5 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in process validation is preferred. 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.

Project/ Process Support Engineer Responsibilities: Lead projects through the design, procurement, installation and commissioning of new equipment or modifications to existing equipment, facilities and engineering assets, in order to meet operational and reliability requirements for existing product and/or new product introduction. Collaborate with internal resources and/or external contractors to plan, schedule and execute capital projects within established timelines and budgets. Ensure equipment and piping design conforms to industrial standards, master specifications, statutory requirements, SHE standards, cGMP compliance and other necessary requirements. Create, review and/or approve cGMP documents such as SOPs, engineering drawings, change orders, etc. and maintain project documentation as necessary. Partner with maintenance and utility teams to ensure maintenance requirements are duly considered in asset design, support updating of maintenance procedures/work instructions and imparting capabilities for asset maintenance. Partner with reliability teams to provide information for setting up maintenance master data, contribute to total asset lifecycle management and support reliability initiatives for all F&E assets. Assist in preparation of capital budget. Support the technology transfer of new products/ processes to the Singapore site as required. Support qualification of new equipment or modifications to existing equipment as required. Support risk assessments, impact assessments and implement CAPA as required. Support in raising Planned event records in Veeva change management system to get GMP impacting project scope approved for execution. Comply with site Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable. Observe all site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately. Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives. About You: Bachelor of Science/Engineering or higher in a scientific or engineering discipline At least 5 years' experience as a design/project engineer/process engineer or related technical discipline in the pharma/biotech industries. Advanced knowledge of engineering concepts, master specifications, equipment validation and qualification, safety principles, quality systems and cGMP requirements.Working knowledge of site finance and procurement policies relating to capital projects. Working knowledge/experience of procedures related to construction, field safety, welding/installation, passivation, polishing and cleaning etc. Experience in working with Veeva planned events change management systems is preferred. Able to develop solutions to complex problems using sound engineering judgment and advanced engineering knowledge. 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. Core Competencies: Willingness to embrace change, ability to adapt to rapidly changing circumstances and courage to challenge status quo when necessary with a view on continuous improvement and achieving targets. Goal-oriented, persistent and driven to achieve results. Willing to take accountability for his/her job assignments. Strong aptitude to acquire and apply engineering knowledge and project management skills. Positive attitude towards continuous learning and contributing his/her expertise within and beyond the assigned work area. Works effectively with other colleagues and partners. Ability to foster a good exchange of ideas from working teams and communicate effectively to members of the project team and stakeholders. Think beyond department and functional boundaries. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

2023 ISPE Singapore Affiliate Conference & Exhibition The ISPE Singapore Affiliate Conference & Exhibition is one of the largest and most respected pharmaceutical manufacturing shows in Singapore for pharmaceutical and biomanufacturing professionals. The annual event highlights the best practices and services from manufacturing facility design to finished products. This year, NPC and CoBetter participated in ISPE 2023 to give product awareness on filtration and single-use products from 23rd to 25th August 2023 at Suntec, Singapore. WhatsApp Image 2023-09-05 at 12.01_edited 1/4 NPC x Cobetter at booth #411.

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.