Job Description
They are seeking to recruit a motivated and self-driven professional to fill in the following position in their Nairobi office:
Reporting to the Operations Manager, this position will be responsible for planning, directing, and coordinating activities in the organization by ensuring compliance with ethical or regulatory standards. Performing internal audits on the effectiveness of compliance policies, submitting compliance reports and serving as a liaison between management and personnel.
Job Duties
Ensuring manufacturing and all production processes are done in compliance to the company SOP and GMP
Ensuring documentation of all manufacturing processes are done correctly and appropriately as per GMP
Taking part in the writing and revision of Batch Manufacturing records, Standard Operating Procedures and other related documents
Liaising with specific regulatory bodies, including Pharmacy and Poisons Board (PPB), Pest Control Products Board (PCPB), Kenya Bureau of Standards, State Department of Veterinary services, NEMA
Developing and maintaining relationships with Key Opinion Leaders – including Government Departments, Regulatory Bodies, Standards Authorities
Playing key role in issues management e.g. product recalls, product related issues & complaints
Drafting, monitoring & training on OSH matters within the company.
Assisting in undertaking the OSH Audits and reporting on non-compliance issues
Qualifications
Good understanding of regulatory environment and registration procedures in Kenya.
Understanding of the processes involved with the following Institutions is desirable: KEBS, KIPI, NEMA, Pharmacy & Poisons Board, Pest Control Products Board
Knowledge of cGMP, ISO practices and standards is desirable.
Good communication, presentation and report writing skills.
Adaptability
Detail oriented
Problem solving and Critical Thinking Skills
Team player with a track record of delivering results
Decision-Making skills
