I am a pharmaceutical manufacturing and compliance professional with more than 15 years of experience in oral solid dosage (OSD) formulation facilities. My background covers GMP manufacturing, quality compliance, validation, batch documentation, and operational excellence within highly regulated environments.
I have worked in USFDA, EU-GMP, MHRA, TGA, WHO-GMP, ANVISA, NAFDAC, and other regulated-market operations. I am experienced in supporting and facing regulatory audits, managing quality systems, and maintaining compliance with cGMP and USFDA 21 CFR Part 211 requirements.
I lead cross-functional manufacturing teams and have managed teams of more than 40 employees. My leadership experience includes employee training, PLMS coordination, productivity improvement, KPI and OEE implementation, and operational support for external manufacturing sites.
My technical expertise includes deviation management, CAPA, change control, OOS handling, BPR review, IPQA, risk assessment, process validation, cleaning validation, equipment qualification, and SOP preparation. I am also a Six Sigma Green Belt certified professional focused on continuous improvement.
I have international operations experience through a three-month deputation to Luanda, Angola, where I helped establish WHO-GMP manufacturing operations and trained local teams. I am actively seeking Manufacturing Manager, QA Manager, or Validation Manager opportunities in USFDA-regulated facilities, including roles with USA visa sponsorship.