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Quality System Specialist Responsibilities: Coordinate with suppliers and verify supplier quality standards are in accordance to the requirements Track and qualify or disqualify suppliers according to standards Liaise with suppliers or support the senior supplier qual specialist to support documentation compilation and GMP/GDP review per procedural requirements Monitor supplier quality performance by tracking product defects, delivery failures and other recorded incidents involving the supplier's failure to meet requirements Support document centre activities Maintain accurate quality records, certifications and database records Compiles Supplier Quality Reports for Management Support regular and routine supplier quality audits to ensure compliance with regulatory standards, waste elimination and continuous improvement Any other task as assigned by Supervisor/Manager Based in Tuas About You: Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Possess GMP systems knowledge with Supplier Quality Management concept Knowledge of quality management system, supplier quality management, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility Must be team player, meticulous, strong analytical and organizational skills Enthusiastic, interested and committed to support Quality systems processes and potential participation in new product introduction activities Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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.

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.

The Full Story About This is your About Page. It's a great opportunity to give a full background on who you are, what you do and what your website has to offer. Double click on the text box to start editing your content and make sure to add all the relevant details you want to share with site visitors. Mission This is a Paragraph. Click on "Edit Text" or double click on the text box to start editing the content and make sure to add any relevant details or information that you want to share with your visitors. Vision This is a Paragraph. Click on "Edit Text" or double click on the text box to start editing the content and make sure to add any relevant details or information that you want to share with your visitors.

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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.

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.

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 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.

NPCyclopedia Interested to find out more? Email us at hello@nusaprime.com ROOT CAUSE ANALYSIS TOOLS Root Cause Analysis is the process of discovering the root causes of problems in order to identify appropriate solutions. Next PROBLEM-SOLVING AND DECISION-MAKING Find out the 4 key aspects of problem-solving and decision-making Next