Validation Manager
2 days ago
Company Introduction:Contributing to the improvement of the quality of life for the Indonesian people with innovative pharmaceuticals and bio solutions.DPI develops and manufactures innovative pharmaceuticals focusing on chemical drugs, cosmetics, and stem cell therapies.Since our establishment in 2022, we have been the first Korean company in Indonesia to obtain GMP certification for stem cell processing. We produce high-quality stem cell therapies derived from umbilical cord and fat tissues, and are expanding our pipeline to include exosomes and immune cells. Beyond stem cells, we are building production facilities for chemical drugs while continuously strengthening our R&D capabilities. In cosmetics, we have also completed GMP certification and are enhancing competitiveness in bio-based functional products. We actively collaborate with Indonesia's top universities, UI, ITB, and IPB to conduct clinical and joint research. We have established a well-organized system that manages the entire pharmaceutical lifecycle, including R&D, manufacturing, quality, and intellectual property. With our own manufacturing facility capable of producing 500 million tablets/capsules annually and backed by Daewoong Pharmaceutical's proven technology, we aim to provide safe and innovative treatment options to Indonesian patients and help improve health and well-being throughout Indonesia.Company CultureAt Daewoong, we believe healthcare is more than medicine — it's about creating better lives. Guided by our WIN-WIN-WIN philosophy, we grow together with our people, customers, and society. We value autonomy, encouraging our team to work in their own best way — where, when, and how they feel most focused. Growth is our priority: we set bold goals, learn continuously, and embrace feedback. Here, work isn't just a job — it's a chance to do something meaningful and impactful.Why Join Us?Top-Tier Salary: We offer a highly competitive salary that reflects your skills and experience in the pharmaceutical, wellness, and beauty industry.Performance-Based Compensation: Your hard work and results are directly rewarded with performance-based compensation, and opportunities for rapid promotions.Autonomous and Immersive Work Culture: Work in an environment that promotes ownership, independence, and deep engagement.Meaningful Work with Societal Impact: Your contribution helps drive a triple-win: employee growth, customer satisfaction, and societal advancement.Expert Training & Knowledge: We are committed to your development. You'll receive specialized training in partnership, including direct learning from Korean expertise.Exclusive Korea Trips: Top performers will be rewarded with a unique trip to Korea, offering a chance to experience our roots and culture firsthand.International Career Path: Exceptional talent will have the opportunity for overseas training or placement, paving the way for a truly global career.Team IntroductionDaewoong Pharmaceutical Indonesia is a proud subsidiary of Daewoong Group, a global healthcare company committed to advancing biotechnology and pharmaceutical innovation. At our Cikarang site, our Engineering Team is the operational backbone, specializing in the maintenance, qualification, and continuous improvement of critical utilities and high-tech manufacturing equipment essential for producing stem cell–based therapies and high-quality cosmetic products. As part of our team, you will work closely with experts across Production and Quality Assurance to ensure facility reliability, system efficiency, and strict adherence to cGMP/CPKB compliance standards. We are a solution-driven, mission-critical team dedicated to leveraging technical excellence to support Daewoong's global leadership in healthcare innovation and operational reliability.Your Role in this Journey:1) Establishing a Validation Master Plan to cover all validation and qualification activities in PT. Daewoong Pharmaceutical Indonesia.2) Coordinate calibration schedule and realization for all GMP measuring instruments in DPI.3) Supervise, provide input and direction on the job descriptions and responsibilities of Validation team member.4) Evaluating reports related to calibration, qualification and validation (cleaning validation, process validation, aseptic process simulation, computer system validation).5) Giving support related with regulatory requirements which required any validation report.6) As an auditor in the internal audit program and self-inspection with another auditor team periodically.7) Participate in the external audit implementation (audit to supplier and other parties).8) Collaborate with other departments related with schedule and result of qualification and/or validation.9) Evaluate the SOP, Work Instruction and Forms that has been made in the company and determine and supervise the implementation of a record keeping system of all activities.10) Established training and development program of Validation team member by arranging internal/external training, supervise work discipline of staff and do performance evaluation.11)Manage the yearly budget for Validation Department and ensure realization within budget.12) Working together, communicate effectively and keep the well relationship with other departments.Who We're Excited to Meet1). Bachelor degree from pharmacist or pharmaceutical engineering or relevant.2). Minimum 10 years experience in validation field from pharmaceutical industry.3). Having experience and knowledge in validation (cleaning validation, process validation, computerized system validation), qualification and calibration in pharmaceutical industry.4). Able to speak English both oral and written.5). Good communication skills - verbal and written.6). Able to coordinate and work together with team, can communicate internally and between department effectively.7). Willing to be based in Cikarang.Preferred:1). Having experiences with qualification in new facility construction.2). Having experiences to facing regulatory audit related with new GMP certification.Recruitment Details:ㆍ Application > Aptitude Test > 1st Interview > 2nd Interview > Compensation Negotiation > Final OnboardingOur Commitment at Daewoong:[Top Treatment & Performance-based Incentive]Top-tier salary structurePerformance-based incentive system : Rewards based on achievements, with promotions tied to skills and competencies.Provide incentives based on product sales[A Growth Platform for Your Career Growth]Exposure to the entire drug development and lifecycle processOpportunity to collaborate with cross-functional global teams (medical clinical, regulatory, commercial)Direct involvement in scientific strategy and decision-makingExperience in stakeholder engagement with Key Opinion Leaders, researchers, and regulatory bodiesDevelopment of medical writing and scientific communication expertiseHands-on contribution to clinical trial design, data interpretation, and publicationsGrowth in pharmacovigilance and drug safety knowledgeBuilding leadership skills through project ownership and cross-team collaborationAccess to continuous medical education, trainings, and global learning resourcesClear career path towards senior medical affairs, clinical leadership, or regional/global roles[Opportunity for Global Stage Experience]Korea trip support for top performersProvision of opportunities to work in Korea for outstanding talentsGreat Workplace, Daewoong GroupDaewoong Group is a major global healthcare leader from Korea, operating in diverse fields including pharmaceuticals, biotechnology, medical devices, and health supplements. With a presence in over 100 countries and a network of 8 branches across Asia and the US, Daewoong drives innovation through 5 worldwide R&D centers and partners with more than 100 companies globally.In Indonesia, Daewoong employs over 360 talented professionals working across multiple locations including Jakarta, Bali, Bekasi, and Surabaya. We are committed to expanding our business further while considering Indonesia a trusted partner growing together. Daewoong actively invests in talent development and contributes to local communities through various CSR initiatives focused on education, health, and social welfare.By joining Daewoong, you become part of a company with the scale, vision, and resources to empower your career and make a global impact in healthcare.Global Presence:Founded in 1945, a global healthcare leaderTop in overseas subsiGlodiaries among Korean pharma8 Branch Operations in Asia & US5 R&D Centers Worldwide100+ Partners WorldwideNo.1 pharmaceutical company in KoreaOver 4,500 employees in Korea100+ Indonesian Talents Working in Korea360+ Employees in Daewoong IndonesiaCelebrating Our Journey:Outstanding Foreign Investment CompanyAward by the Indonesian Government (2022)Best Workplace' in Asia (2023)Best Workplace' in Korea (2022)Recognition for Women-Friendly CorporateCulture & Diversity Management Award (2022)Global Pharmaceutical R&D Innovation Award (2021)Meet Our Inspiring People:Trust + Autonomy = Growth | My Journey to GM in 3 Years From Analyst to GM in 3 Years Here's How I Did It The Trust That Let Me Work My Way And Grow Faster A Company That Rewards You for What You Actually Do
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Validation Manager
2 days ago
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