Compliance Officer (Pharmaceutical) at Ascentech Services Limited

Overview

• We are seeking a highly skilled and experienced Compliance Officer to join our pharmaceutical company in Calabar.
• The ideal candidate will have a strong background in regulatory compliance within the pharmaceutical industry, with a keen understanding of local and international regulations governing pharmaceutical manufacturing, distribution, and marketing.
• This role requires meticulous attention to detail, excellent analytical skills, and the ability to effectively communicate and collaborate with various stakeholders to ensure compliance with all relevant standards and regulations.

Responsibilities

• Regulatory Compliance: Ensure adherence to all local, national, and international regulations governing pharmaceutical operations, including but not limited to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Clinical Practices (GCP).
• Documentation Management: Oversee the development, maintenance, and organization of all regulatory documents, including product registrations, licenses, and certifications required for pharmaceutical operations.
• Risk Assessment:Conduct regular risk assessments to identify potential compliance issues and develop strategies to mitigate risks effectively.
• Audits and Inspections: Coordinate and participate in internal and external audits and inspections, ensuring all findings are addressed promptly and appropriately.
• Training and Education: Develop and deliver compliance training programs for employees at all levels of the organization to ensure awareness and understanding of regulatory requirements and company policies.
• Quality Management Systems: Collaborate with quality assurance teams to implement and maintain robust quality management systems that meet regulatory standards and support continuous improvement initiatives.
• Investigations and Corrective Actions:Investigate compliance deviations, complaints, and incidents, and implement corrective and preventive actions to prevent recurrence.
• Monitoring and Reporting: Establish mechanisms for monitoring compliance metrics and prepare regular reports for management review, highlighting areas of strength and areas needing improvement.
• Vendor and Supplier Management: Evaluate the compliance status of vendors and suppliers and ensure that all contracted services meet regulatory requirements.
• Continuous Improvement: Stay abreast of changes in regulatory requirements and industry best practices, and proactively recommend and implement enhancements to the company's compliance program.

Qualifications

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Regulatory Affairs, or a related field. Advanced Degree preferred.
• Minimum of 5 years of experience in regulatory compliance roles within the pharmaceutical industry, with specific experience in drug manufacturing, distribution, or marketing.
• In-depth knowledge of Nigerian pharmaceutical regulations and familiarity with international regulatory frameworks (e.g., FDA, EMA).
• Strong understanding of quality management systems, risk assessment methodologies, and audit processes.
• Excellent communication, interpersonal, and leadership skills.
• Proven ability to work collaboratively across departments and influence stakeholders at all levels of the organization.
• Certification in regulatory affairs or compliance (e.g., RAC) is a plus.