Batch Record Reviewer (GMP Manufacturing) Are you passionate about quality, compliance, and ensuring manufacturing excellence? We are looking for a detail-oriented Batch Record Reviewer to join our team and play a key role in supporting timely batch release within a regulated GMP environment.
RESPONSIBILITIES Review executed batch records in accordance with procedures and regulatory requirement Track, monitor, and report batch record review activities and critical metrics to ensure on-time batch releases Collaborate closely with Operations and raise observations in a timely manner Ensure manufacturing documentation meets GMP and quality standard
SKILLS AND EXPERIENCE Minimum 2 years' experience in a GMP manufacturing environment Experience with quality procedures, SOP execution, and batch documentation Previous batch record review experience Strong attention to detail and ability to work independent Excellent communication and stakeholder management skill Experience with MES systems, ideally Pharma Suite
QUALIFICATIONS Bachelor's or Master's degree (or equivalent experience) in Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy, or another scientific discipline
Languages German language skills are a strong advantage
KPC – International is an Equal Opportunity Employer
#J-18808-Ljbffr
RESPONSIBILITIES Review executed batch records in accordance with procedures and regulatory requirement Track, monitor, and report batch record review activities and critical metrics to ensure on-time batch releases Collaborate closely with Operations and raise observations in a timely manner Ensure manufacturing documentation meets GMP and quality standard
SKILLS AND EXPERIENCE Minimum 2 years' experience in a GMP manufacturing environment Experience with quality procedures, SOP execution, and batch documentation Previous batch record review experience Strong attention to detail and ability to work independent Excellent communication and stakeholder management skill Experience with MES systems, ideally Pharma Suite
QUALIFICATIONS Bachelor's or Master's degree (or equivalent experience) in Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy, or another scientific discipline
Languages German language skills are a strong advantage
KPC – International is an Equal Opportunity Employer
#J-18808-Ljbffr
eBR Reviewer Arbeitgeber: KPC International
KPC – International bietet eine dynamische und unterstützende Arbeitsumgebung, in der Qualität und Compliance an erster Stelle stehen. Als Batch Record Reviewer haben Sie die Möglichkeit, in einem regulierten GMP-Umfeld zu arbeiten, das nicht nur Ihre berufliche Entwicklung fördert, sondern auch ein starkes Teamgefühl und enge Zusammenarbeit mit verschiedenen Abteilungen betont. Unsere Mitarbeiter profitieren von kontinuierlichen Schulungen und einer Kultur, die Innovation und Exzellenz schätzt.
