Customer Support Cape Town - South Africa
Vela Personnel
Purpose: The company requires the services of a highly competent and experienced Regulatory Affairs Scientist for the Regulatory Affairs Department Key Job Outputs: Compilation and update of documents to be submitted to regulatory authorities, this includes the compilation of Common Technical Documents (CTDs) in accordance with relevant guidelines and regional requirements Compilation, update and/ or amendment of internal document relating to the testing and manufacture of Active Pharmaceutical Ingredients (APIs) Responding to customer (both internal and external) and regulatory authority queries 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 /or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations Compilation of process qualification protocols and reports 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 Experience: Good knowledge of chemistry (analytical and organic), knowledge of local and international pharmaceutical regulations guidelines would be highly advantageous Excellent written and verbal communication skills and the ability to interact well with internal and external customers Minimum of 3years 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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