Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.
Responsible for executing technology transfer projects (from trial planning, scale‑up, validation to commercial readiness) and new equipment investment activities (from feasibility, technical assessment, URS, FAT/SAT, IQ/OQ/PQ to release to production). Coordinate cross‑functional trial, validation, and optimization activities; ensure data‑driven decisions, GxP‑compliant documentation, and delivery in line with KPIs, timelines, and regulatory expectations.
Technology Transfer & Process Validation
- Develop and execute process validation protocols; monitor validation batches, perform sampling, document parameters, and prepare validation reports.
- Analyze process and quality trends, ensure process robustness and capability, and manage technical risks through science‑based justification and change control.
- Perform evaluation of new equipment, including feasibility, technical fit, and preparation of technical recommendations.
- Support development of URS and coordinate with related departments during FAT/SAT and IQ/OQ/PQ to ensure equipment is qualified and integrated as planned.
- Follow up on issues, support troubleshooting, and assist in performance verification and improvement actions during and after implementation.
- Prepare and execute lab trial batches to support material changes, process adjustments, troubleshooting, and product/process improvement.
- Collaborate with QA and QC to perform stress tests, assess product behavior under challenging conditions, and evaluate process impact.
- Work with QA/QC to plan, execute, and monitor stability studies; ensure compliance with quality and regulatory requirements.
- Analyze test results with cross‑functional teams to support decision‑making for proposed changes.
- Prepare technical reports summarizing objectives, results, conclusions, and recommendations.
Qualification
- Bachelor’s degree in pharmacy or related field.
- Minimum 2–3 years of experience in R&D, production, or quality assurance in a pharmaceutical company.
- Good understanding of GMP, pharmaceutical manufacturing processes, and process validation requirements.
- Experience with equipment qualification (IQ/OQ/PQ), project coordination, and stakeholder management is preferred.
- Experience in trial batch preparation, stress testing, and stability studies are an advantage.
- Knowledge or experience in pharmaceutical regulations and drug registration is a plus
Functional & Technical
- Solid understanding of manufacturing equipment, key process parameters.
- Experienced in core technology transfer activities: scale‑up, process adaptation, sampling, and reviewing technical dossiers.
- Able to execute equipment investment and qualification (technical assessment, URS input, FAT/SAT coordination, IQ/OQ/PQ readiness).
- Collaboration & Communication
- Work effectively with Production, QA, QC, Engineering, and other functions.
- Communicate clearly and provide timely updates to stakeholders.
- Problem-solving & Analytical Skills
- Strong attention to detail in recording and analyzing data.
- Prepare clear technical summaries and reports.
- Apply basic root cause and problem‑solving tools.
- Language Skills
- Good reading comprehension of technical English.
- Basic English communication for emails and discussions
Opella là một công ty chăm sóc sức khỏe tập trung vào sản phẩm tự chăm sóc với danh mục sản phẩm tinh khiết nhất và lớn thứ ba trên thị trường Thuốc không kê đơn (OTC) & Vitamin, Khoáng chất & Thực phẩm bổ sung (VMS) trên toàn cầu, thuộc sở hữu của Opella Healthcare International SAS. Công ty này có văn phòng đại diện tại thành phố Hồ Chí Minh và có trụ sở chính tại Pháp, nhưng tầm nhìn hướng đến toàn cầu. Opella sở hữu nhiều thương hiệu nổi tiếng như Allegra, Dulcolax, Enterogermina và Doliprane, được tin dùng rộng rãi trên thế giới. Cốt lõi của sứ mệnh này là 100 thương hiệu được yêu thích, đội ngũ toàn cầu gồm 11.000 người, 13 cơ sở sản xuất tốt nhất và 4 trung tâm phát triển khoa học và đổi mới chuyên biệt. Có trụ sở chính tại Pháp, Opella tự hào là nhà sản xuất của nhiều thương hiệu được yêu thích nhất trên thế giới, bao gồm Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale và Mucosolvan. Được chứng nhận B Corp tại nhiều thị trường, chúng tôi là những người chơi tích cực trong hành trình hướng tới con người và hành tinh khỏe mạnh hơn.