Regulatory Affairs / Quality Assurance Officer (W503)
*Analytical, being able to work accurately under pressure with great attention to detail having excellent administration skills and very advanced organisation skills. Independent worker. Any degree with a minimum of 3 years working experience, ideally with a quality assurance background. Proficient in Maths and English. Highly proficient in computer skills (MS Word and MS Excel proficiency is essential). SA citizens residing in Cape Town only.*
Location: Claremont, Western Cape
Description: A company supplying regulatory affairs and quality assurance services is seeking a Regulatory Affairs / Quality Assurance Officer to join their team with responsibilities covering regulatory submissions and quality assurance activities. The RA/QA Officer will provide regulatory and quality assurance support to the business under the supervision of the Regulatory Affairs Manager. Key duties includes but is not limited to: assisting with compilation of electronic and/or hard copy submissions to Regulatory Authorities for medicines or similar products; electronic and hard copy filing of all documentation relating to these regulatory submissions and accurate record keeping of submissions; maintenance of regulatory and other related databases; drafting or reviewing Regulatory Affairs related documents, including package inserts, patient information leaflets, labels, artwork, adverts, responses to Regulatory Authorities, etc; communicating with Regulatory Authorities, including tracking submissions and responses to Regulatory Authority queries; assisting with maintaining company licencing requirements, product registration certificates and the generation of documentation related to legal compliance; assisting with generation of Quality Assurance related documentation and maintenance of the Quality Assurance database; assisting with reporting and tracking of product complaints, product quality reviews, audit reports, reviewing and writing SOPs. Arrangement and tracking of all document transfers to and from the business. Handling of all payment requests and tracking. To provide general office admin support, Client and service provider liaison.
Key Requirements: Analytical, being able to work accurately under pressure with great attention to detail and good administration skills. Advanced organisation skills. Independent worker within a team environment. Any degree with a minimum of 3 years working experience, ideally with a quality assurance background. Proficient in Maths and English. Highly proficient in computer skills (MS Word and MS Excel proficiency is essential). SA citizens residing in Cape Town only.
Additional Requirements: Must be willing to travel, if required to do so by the company. Good verbal and written communication skills; proficiency in Afrikaans and (Pure) Science is beneficial. Previous quality assurance work experience will be very beneficial.
Remuneration: Market related.
Starting date: As soon as possible.
*Only candidates that meet all the requirements should apply
**Please quote “Regulatory Affairs Officer (W503)” in the subject line
***Only candidates that are shortlisted will be contacted