Senior Batch Record Review Specialist (Nights)
Core
Review, release, and second-check batch record documentation to ensure compliance with cGMPs, SOPs, and regulatory requirements for pharmaceutical manufacturing.
Role type
Senior Batch Record Review Specialist (Quality Assurance)
Builds
Certified batches of medicines and vaccines ready for patient distribution
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
cGMP knowledge, Good Documentation Practices (GDP), deviation investigation support, CAPA support, batch release processes, certificate creation (C of A, C of M, C of C), regulatory compliance, quality guidance to production, audit support, documentation error identification, GMP awareness promotion
Preferred skills
Bachelor's degree in life sciences/quality, MERP system experience, LIMS familiarity, continuous improvement tools, IT applications proficiency, pharmaceutical process knowledge
Technologies
MERP, LIMS, Microsoft Office
Responsibilities
Review and release batch records; coordinate production deviation investigations; assist with NRFT issues; provide quality guidance to production; support internal and regulatory audits; create certificates of analysis/manufacture/compliance; identify and report documentation errors; advise production staff on quality issues.
Seniority
Senior, hands-on IC
