Pharmaceutical Compliance Specialist

Key Duties


Formulates strategies and procedures to ensure regulatory compliance.
Guarantees all legal and regulatory documents are filed and monitors compliance with laws and regulations.
Accountable for authorization of production, Batch Manufacturing Record (BMRs), and document review
Ensure all professional activities undertaken by you or under your supervision are covered by adequate professional indemnity insurance.
Guarantees Good Manufacturing Practice (GMP) is followed
Handles product registration with the National Agency for Food Drugs. Administration and Control (NAFDAC)
Ensures that Production and manufacturing operations adhere to current WHO GMP, National Regulatory Authority Standard (NAFDAC, PCN, Federal Ministry of Labour and Productivity), and NIS ISO 9001:2015.
Coordinates with organizations such as the Pharmaceutical Group of the Manufacturers Association of Nigeria (PMGMAN), National Agency for Food Drugs Administration and Control (NAFDAC), Pharmacists Council of Nigeria (PCN), Pharmaceutical Society of Nigeria (PSN), Federal and State Ministries of Health, Customs and Excise Authorities
Manages market complaints in collaboration with QC/QA
Supervises the registration and renewal of the premises (Including Warehouse) license with the Pharmacist Council of Nigeria (PCN) annually as stipulated in chapter 152 of the pharmacy law.
Oversees the activities of the regulatory unit concerning compliance, registration, and renewal of licenses.
Remains current with GMP, Pharmacovigilance, and CGMP guidelines regarding product development and compliance
Handles processing and obtaining chemical permits for Dana Group of companies
Ensures adherence to all legal and professional requirements governing operations in the premises
Advises management and internal clients on regulatory compliance
Participates in advocacy, public corporate responsibility programs and maintains cordial relationships with stakeholders in our business


Qualifications


Minimum of B. Pharm /D.Pharm
Must be a registered Pharmacist
At least 5 years' experience in production
Exceptional communication Skills
Strong negotiation and relationship management abilities.