Superintendent Pharmacist (Regulatory Affairs)
Dana Group
Job Description:
There is a vacancy for the role of Superintendent Pharmacist at Dana Pharmaceuticals Limited (Lagos). Candidate should possess at least 6 years experience in a manufacturing setting.
Responsibilities
馃搷Develops strategies and procedures to ensure regulatory compliance.
馃搷Ensure all legal and regulatory documents are filed and monitor compliance with laws and regulations.
馃搷Responsible for authorization of production, Batch Manufacturing Record (BMRs), and document review
馃搷Make sure all professional activities undertaken by you or under your control are covered by adequate professional indemnity cover.
馃搷Ensures Good Manufacturing Practice (GMP) is adhered to
馃搷Registration of products with the National Agency for Food Drugs. Administration and Control (NAFDAC)
馃搷Ensure that Production and manufacturing operations are carried out in compliance with the current WHO GMP, National Regulatory Authority Standard (NAFDAC, PCN, Federal Ministry of Labour and Productivity), and NIS ISO 9001:2015.
馃搷Liaising with bodies 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
馃搷Handling of market complaints with QC/QA
馃搷Oversee the registration and renewal of the premises (Including Warehouse) license with the Pharmacist Council of Nigeria (PCN) annually as contained in chapter 152 of the pharmacy law.
馃搷Oversee the activities of the regulatory unit as it concerns compliance, registration, and renewal of licenses.
馃搷Stay abreast of GMP, Pharmacovigilance, and CGMP guidelines regarding product development and compliance
馃搷Processing and obtaining chemical permit for Dana Group of companies
馃搷Ensure that all legal and professional requirements covering operations in the premises are adhered to
馃搷Guiding the management and internal clients to comply with regulatory requirements
馃搷Participation in advocacy, public corporate responsibility programs and maintains a cordial relationship with stakeholders in our business
Requirements
路 Minimum of B. Pharm /D.Pharm
路 Must be a licensed Pharmacist
路 At least 6 years experience in a manufacturing setting
路 Excellent communication Skills
路 Good negotiation and relationship management skills.
Please send CVs (pdf) to