Technical Support Cape Town - South Africa
Vela Personnel
Purpose: The company requires the services of a highly competent and experienced Regulatory Affairs Scientist (Development and Technical Support) for the Regulatory Affairs Department Key Job Outputs: Compilation and/ or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations Performing risk assessments to evaluate the potential presence of elemental, genotoxic and/ or nitrosamine impurities according to relevant regulatory guidelines Compilation of process qualification protocols and reports Investigating, evaluating and reporting on process performance and proposed changes Ensuring that annual product quality reviews are compiled according to cGMP standards and adverse trends and potential process improvements identified Implementing changes according to established company procedures relating to the testing and manufacturing process Compilation and update of documents to be submitted to regulatory authorities, this includes compilation of common technical documents Ensuring that related databases are updated to allow for the capturing of API data Core Competencies: Good interpersonal kills Good organisational and systems implementation skills Exceptional attention to detail and accuracy Good communication (written and verbal) with excellent report writing and document reviewing skills, including the ability to evaluate data critically Ability to perform task concurrently Self-motivated Qualifications: Degree in Chemistry/ Pharmaceutical Sciences or equivalent qualification as per the National Qualification Framework (NQF) Experience: Good knowledge of chemistry (analytical and organic), statistical knowledge would be advantageous Minimum of 1 year experience in pharmaceutical, cGMP, or chemical manufacturing environment Proven technical documentation compilation skills, with the ability to critically evaluate and Interpret data MS Office computer literacy, particularly the following applications: word, Axcel, Outlook, Teams, access, and PowerPoint, Minitab and/ or EXTEDO proficiency would be advantageous Salary: Market related Should you not hear from us within 2 weeks, kindly consider your application as unsuccessful. All personal information received will be processed in accordance with The Protection of Personal Information Act No. 4 OF 2013
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