Quality Assurance Senior Engineer DHR Review / Batch Release
Core
Reviewing and releasing manufacturing and packaging documentation (Batch Records) for completeness and accuracy, ensuring compliance with GMP guidelines and internal quality standards.
Role type
Senior Quality Assurance Engineer (Batch Release)
Builds
Pharmaceutical/aesthetic medical device production batches
Domain
Biopharmaceuticals / Aesthetic Medicine / GMP-regulated manufacturing
Deliverable
client delivery
Required skills
GMP guidelines knowledge, regulatory requirements knowledge, document review, deviation identification, corrective action initiation, audit support, time management, structured work approach, self-organization, reliability, problem-solving, proactive work style, MS Office proficiency, English (fluent)
Preferred skills
Degree in Pharmacy, Chemistry, Biotechnology or equivalent vocational training with relevant experience, experience in ISO13485 regulated environments
Technologies
MS Office
Responsibilities
Review and release Batch Records for completeness and accuracy, Verify quality-relevant documents, Archive documents, Ensure compliance with GMP guidelines and internal quality standards, Identify and document deviations and initiate corrective measures, Support internal and external audits
Seniority
Senior, hands-on IC
