Manufacturing Compliance Coordinator
Tentang pekerjaan
Rangkuman Get Karier, bukan salinan iklan aslinyaManufacturing Compliance Coordinator di pabrik Lonza Geleen yang menjaga kesiapan inspeksi GMP untuk produksi obat terapi lanjutan (advanced therapy). Tugasnya meninjau batch record dan SOP, menangani deviation, change control, dan CAPA, serta mendukung audit. Posisi untuk lulusan baru sampai pengalaman empat tahun, kerja penuh di lokasi pabrik. Gaji pokok EUR 41.250 sampai EUR 57.750 (sekitar Rp840 juta sampai Rp1,2 miliar) per tahun.
Kualifikasi
Yang perlu kamu siapkan, versi ringkasWajib:
- S1 atau setara di bidang Bioteknologi, Life Sciences, atau bidang terkait
- Pengalaman 0 sampai 4 tahun di manufaktur, farmasi, atau bioteknologi
- Pemahaman cGMP yang baik
- Komunikasi tertulis dan lisan dalam Bahasa Inggris
Nilai tambah:
- Latar belakang farmasi
- Pengalaman di produk terapi lanjutan (ATMP) atau lingkungan yang sangat diregulasi
Deskripsi & syarat asli
Teks asli dari perusahaan, apa adanya. Tidak kami terjemahkan atau ubah.Manufacturing Compliance Coordinator Geleen, Netherlands Join Lonza’s Manufacturing team in Geleen as a Manufacturing Compliance Coordinator and play a key role in maintaining GMP readiness and supporting the delivery of high-quality advanced therapy medicines. You will work across Manufacturing, Quality Assurance and other functions to investigate quality events, strengthen compliance and drive continuous improvement.
This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. A variety of benefits dependent on role and location.
The full list of our global benefits can be found here: Lonza Global Benefits . The full-time annual base pay for this position in the Netherlands is expected to range between EUR 41,250 and EUR 57,750. Initial salary placement within this range will be determined based on role-related factors such as experience, qualifications, and expected contribution. What you will do: Support the Manufacturing Compliance Lead in maintaining readiness for routine GMP inspections and pre-approval inspections.
Initiate, review and revise batch records, SOPs, protocols, work instructions and other GMP-related documentation. Investigate and manage quality events, including deviations, change controls and CAPAs, coordinating implementation, follow-up and timely closure in accordance with GMP requirements. Work closely with Manufacturing Team Leads, Production Operators, Biotech Associates, Quality Assurance and other stakeholders to resolve quality issues and maintain compliance.
Identify potential risks to manufacturing delivery, escalate issues appropriately and independently seek practical solutions within established procedures. Support internal and external audits and contribute to consistent GMP compliance across the Manufacturing organisation. Drive continuous improvement in processes, planning and training, while providing cover for the Manufacturing Compliance Lead when required.
What we are looking for: A Bachelor's degree, or equivalent qualification, in Biotechnology, Life Sciences or a related field, ideally with a pharmaceutical background. Entry-level to early-career experience, with up to four years of relevant experience in manufacturing, pharmaceutical or biotechnology environments. A good understanding of current Good Manufacturing Practice (cGMP), ideally within the manufacture of advanced therapy medicinal products or another highly regulated environment.
Strong planning, prioritisation and problem-solving skills, with the ability to adapt your approach when new information becomes available. The ability to assess quality-related decisions and recognise when to consult Manufacturing Compliance or Quality Assurance colleagues. Strong written and verbal communication skills in English, with the ability to work effectively across departments and build constructive working relationships.
A proactive, collaborative and continuous-improvement mindset, with a positive attitude, strong attention to detail and a commitment to quality and safety. About Lonza At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together.
Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
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