Associate Director – Manufacturing Electronic Batch Record (mebr)
AstraZeneca
Singapore, Singapore
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Electronic batch record (ebr) systems experience
Gmp manufacturing industry experience
Shopfloor operations and process execution knowledge
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AstraZeneca is seeking an Associate Director for their Manufacturing Electronic Batch Record (MEBR) role at their new biologics manufacturing campus in Singapore. The position is pivotal in overseeing the Electronic Batch Record capability, ensuring compliance and efficiency in manufacturing processes.
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Job Summary
Accountable for establishing and leading the Electronic Batch Record (EBR) capability at site, owning how manufacturing processes are translated into practical, executable batch records within MES.
Collaborate with Global IT and cross-functional partners to secure timely MEBR readiness for various manufacturing processes and ensure a smooth transition into routine GMP manufacturing.
Recruit, develop and lead a high-performing MEBR team, collaborate with the QA team to set up a review-by-exception process, ensuring timely review of EBR with improved efficiency.
Matching Summary
Match Score: 75
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AstraZeneca is seeking an Associate Director for their Manufacturing Electronic Batch Record (MEBR) role at their new biologics manufacturing campus in Singapore. The position is pivotal in overseeing the Electronic Batch Record capability, ensuring compliance and efficiency in manufacturing processes.
**
Skills & Requirements
Must-have
Electronic Batch Record (EBR) systems experience
GMP manufacturing industry experience
Shopfloor operations and process execution knowledge
Regulatory expectations and data integrity (ALCOA+)
Transitioning from project/startup to commercial operations
Nice-to-have
Lean Six Sigma certifications
Experience in FDA/EMA/MHRA/NMPA inspections
Advanced skills in PAS-X platform
Leading change management initiatives
Utilizing EBR data for process improvement
Key Requirements
Degree in Engineering, Pharmaceutical Sciences, or related field
Strong experience in GMP manufacturing industry within large matrix organization
Proven experience in batch record creation, review, and management
Experience working with electronic batch record systems (as a user/owner)
Demonstrated leadership in transitioning from project/startup into commercial operations