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- 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 Operation Specialist | NUSANTARA PRIME CONS
Quality Operation Specialist Responsibilities: Ensure that products manufactured meet approved company policies, processes and procedures Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities. Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out. Release incoming material, process, and product batches. Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product. Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies. Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times. Participate and support new product introduction, operation excellence projects and other tasks as assigned by management About You: Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics Minimum of 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment. Experience in SAP, Trackwise are preferred Ability to quickly know products and processes in order to assess quality issues Committed to quality and maintain a high standard of work at all times Demonstrates the highest levels of integrity and a strong work ethic Good knowledge of GxP requirements and regulations Good planning and scheduling skills Good communication and interpersonal skills both verbal and written Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Sale Executive | NUSANTARA PRIME CONS
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 System Specialist | NUSANTARA PRIME CONS
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.
- CQV Engineer | NUSANTARA PRIME CONS
CQV Engineer Responsibilities: Develop, review and/or approve validation lifecycle documents and protocols/reports and deliverables in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. Take lead and review project design documents (P&IDs, PFDs, URS etc.) Define user requirements and create SOPs or documentation related to the validation activities Manage qualification execution and lead validation deviation investigation encountered in qualification. Create and review validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities Participate in site Validation Maintenance Program. Write execution related deviations and change requests Support change implementation on site. Manage Change Control to update SOPs, Risk Assessment, Requirement Traceability Matrix and/or Automation System Life cycle documentation as needed Perform validation documentation and/ or support validation documentation in accordance to the division procedures Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager Ensure validation execution meets compliance, validation standards and cGMP requirements Any other task as assigned by Supervisor/Manager About You: Diploma/Degree in Engineering or Science Disciplines with 3 to 5 years experience in Pharmaceutical Industry Proven track record in Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV) In-depth knowledge on cGMP, GDP and ASTM E2500 Proactive and self-motivated Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations) Effective Project Management, leadership, communication and interpersonal skills Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Associate Validation Engineer | NUSANTARA PRIME CONS
Associate Validation Engineer Responsibilities: Develop, review and/or approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. Manage qualification execution and lead validation deviation investigation encountered in qualification. Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities Participate in site Validation Maintenance Program. Write execution related deviations and change requests. Support change implementation on site. Any other task as assigned by Supervisor/Manager About You: Diploma / Bachelor Degree in Engineering / Science or related Pharmaceutical courses. Min. 2 years' experience in Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, Cleaning validation and temperature mapping is preferred. Fresh Graduates welcome to apply. Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility. Good oral and written communication skills Meticulous and Systematic Team player, with strong focus on safety, quality, and timeline Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Validation Engineer | NUSANTARA PRIME CONS
Validation Engineer Responsibilities: Support equipment/system qualification and cleaning validation Develop validation lifecycle document and protocols/reports in accordance with relevan t policies, standards, procedures and guidelines, and completed in a timely fashio n Manage qualification/validation execution and lead the validation deviation investigation s encountered during qualification/validation Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities Participate in site Validation Maintenance Program Support Change Implementation on site Any other tasks as and when assigned by supervisor Support other technical changes and duties as required About You: Engineering/Science Degree or higher from recognised institution At least 5 years of experience in Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, Cleaning validation and temperature mapping is preferred. Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility Good oral and written communication skills. Meticulous and Systematic Team player, with strong focus on safety, quality and timeline Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- Associate CSV Engineer | NUSANTARA PRIME CONS
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.
- About Us | NUSANTARA PRIME CONS
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.
- Current Projects | NUSANTARA PRIME CONSULTING
CURRENT PROJECTS 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.