Senior Special Advisor, GMP and Regulatory Affair

• Collaborate with the project team and relevant stakeholders to incorporate GMP requirements into the design, layout, and construction plans of the vaccine manufacturing plant.
• Review and provide guidance on architectural and engineering designs to ensure compliance with GMP principles, including cleanroom design, HVAC systems, utility layouts, and equipment placement.
• Participate in construction site inspections and provide feedback on GMP-related aspects, such as materials handling, sanitary facilities, and waste management.
• Conduct risk assessments to identify potential GMP-related risks during the construction phase and propose mitigation measures.
• Develop and implement GMP-related procedures and protocols specific to the construction activities, including material handling and storage, construction hygiene, and environmental controls.
• Collaborate with quality assurance and quality control teams to ensure adherence to GMP standards in construction material selection, equipment installation, and validation processes.
• Train and educate construction personnel and subcontractors on GMP requirements, best practices, and safety protocols relevant to the vaccine manufacturing plant construction.
• Monitor and assess contractor performance and compliance with GMP guidelines, ensuring timely resolution of any non-compliance issues.
• Collaborate with regulatory authorities and support inspections or audits related to GMP compliance during the construction phase.
• Provide regular progress reports and updates on GMP-related activities to project stakeholders.

Educational Back Ground

• Masters degree or Bachelors degree in pharmacy, chemistry, or pharmaceutical engineering.
• Additional certifications or specialized training in GMP principles and construction management would be advantageous.

Work Experience

• 15 years of proven experience in regulatory affair and GMP, manufacturing, and quality assurance for a Masters degree or 17 years of proven experience in regulatory affair and GMP, manufacturing, and quality assurance for a Bachelors degree.

PROFESSIONAL KNOWLEDGE, SKILLS AND ATTRIBUTES, REQUIRED

• In-depth knowledge of GMP guidelines and requirements for pharmaceutical manufacturing facilities, particularly in vaccine production.
• Proven experience in GMP compliance for pharmaceutical facility construction projects, including familiarity with cleanroom design, HVAC systems, utilities, and equipment installation.
• Strong understanding of construction processes, safety protocols, and project management principles.
• Excellent communication and interpersonal skills to effectively collaborate with cross- functional teams, contractors, and regulatory authorities.
• Attention to detail and ability to review architectural and engineering plans to identify GMP compliance issues.
• Strong problem-solving and analytical skills to address GMP-related challenges during the construction phase.
• Familiarity with regulatory requirements and the ability to interact with regulatory authorities during inspections or audits.
• Strong organizational and time management skills to ensure GMP activities are integrated into the construction project timeline.
• Knowledge of quality management systems and construction regulations related to pharmaceutical manufacturing facilities.

Reporting

• GMP Lead will report to Project Technical Lead , the project manager, quality assurance department, or senior management
• Language Requirement: Applicants must be proficient in English [speaking, writing, listening and reading]
• Both the Civil service and MoH Human Resource Administration rules and regulations will be applied to guide the day to day services of the advisor.