QSSK- RAA- REGULATORY AFFAIRS ASSISTANT
Job Summary
JOB TITLE: REGULATORY AFFAIRS ASSISTANT
About This Job:
Q-Sourcing Limited trading as Q-Sourcing Servtec is a manpower management solutions firm operating in the East African Region in the countries of Uganda Kenya Tanzania Rwanda and South Sudan.
On behalf of our client we are looking for a competent skilled and experienced Regulatory Affairs Assistant to work in Kenya.
Job Purpose
To ensure business compliance to regulations and standards according to the Good Warehousing Practice as outlined by the Pharmacy and Poisons Board (PPB) and adherence to Standard Operating Procedures that govern compliance to ISO 9001:2015.
Key Responsibilities
1. Regulatory Compliance
Apply for import permits according to the Pharmacy and Poisons Board (PPB) rules.
Ensure all documentation required for official records is filed and easily retrievable.
2. Audits & Non-Conformance Management
Ensure that non-conformances are initiated reviewed and evaluated.
Ensure non-conformances are closed within 30 days of initiation.
Prepare non-conformance trends and reports.
3. Environmental Management
Participate in the implementation of departmental and site Environmental Management System (EMS) objectives.
Ensure EMS objectives are monitored and measured.
4. Documentation & Reporting
Handle all documentation needed for official records in line with established SOPs and working instructions.
Prepare weekly reports on regulatory activities.
Perform any other duties as assigned by Management from time to time.
Education
Diploma in Pharmacy Clearing and Forwarding Information Technology or a related field.
Experience
Experience in document management is required.
Prior exposure to regulatory affairs or compliance roles is an added advantage.
Technical Skills
Computer literacy including proficiency in Microsoft Office applications.
Knowledge of document management systems.
Understanding of regulatory requirements (PPB ISO 9001:2015) is an added advantage.
Core Competencies
Strong attention to detail and organizational skills.
Ability to work under pressure and meet deadlines.
Excellent communication and interpersonal skills.
Integrity and ability to handle confidential information.
Team player with a proactive attitude.
Interested and qualified applicants should submit their applications through the link below.
Note: Only shortlisted applicants will be contacted.
Q-SOURCING SERVTEC IS AN EQUAL OPPORTUNITY EMPLOYER. ANY SOLICITATION WILL LEAD TO DISQUALIFICATION.
Required Skills:
Technical Skills Computer literacy including proficiency in Microsoft Office applications. Knowledge of document management systems. Understanding of regulatory requirements (PPB ISO 9001:2015) is an added advantage. Core Competencies Strong attention to detail and organizational skills. Ability to work under pressure and meet deadlines. Excellent communication and interpersonal skills. Integrity and ability to handle confidential information. Team player with a proactive attitude.
Required Education:
EducationDiploma in Pharmacy Clearing and Forwarding Information Technology or a related in document management is exposure to regulatory affairs or compliance roles is an added advantage.