ELVIS OPOKU BAAH

• Support companies in strengthening Quality Management Systems (QMS) and regulatory compliance activities.
• Conduct gap analyses against ISO 13485 and GMP regulatory frameworks to identify compliance risks and improvement opportunities.
• Contribute to CAPA implementation and quality documentation updates to support inspection readiness.
• Assist in aligning production training programs with deviation trends and CAPA outcomes to strengthen operational compliance.
• Collaborate with multidisciplinary teams to ensure effective execution of regulatory and quality projects.

Key Achievements

• Improved batch documentation accuracy by 15% through documentation initiatives and operator support.
• Reinforced contamination control strategies and cleanroom behaviour to maintain aseptic manufacturing standards.
• Provided onboarding support to new operators, reinforcing GMP, GDP, and cleanroom expectations.

Responsibilities

• Execute aseptic compounding and filling operations in Grade A/B cleanroom environments under EU GMP Annex 1 requirements.
• Ensure GMP-compliant manufacturing operations through accurate completion of batch records and production documentation.
• Support deviation investigations and root cause analysis in collaboration with supervisors and Quality Assurance teams.
• Participate in equipment qualification, cleaning validation and change control activities supporting compliant facility operations.
• Review electronic batch records (EBR) to ensure data integrity and documentation accuracy prior to QA review.
• Design and deliver GMP onboarding and cleanroom behaviour training for new production operators.
• Collaborate with Quality Assurance, Engineering and Production teams to maintain operational readiness and regulatory compliance.

• Operated synthesis and blending processes under ISO 9001 compliance.
• Contributed to process improvements increasing yield and reducing rework.
• Supported validation and equipment qualification with engineering teams.
• Maintained adherence to EHS, SOPs, and data integrity standards.