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Regulatory Affairs Scientist

Aspen Pharmacare Holdings - Epping, Cape Town, Western Cape

Full-Time | Chemical Engineering

Closing date ayichazwanga

Aspen Pharmacare Holdings Regulatory Affairs Scientist Epping, Cape Town

Purpose

  • Fine Chemicals requires the services of a highly competent Regulatory Affairs Scientist for the Regulatory Affairs Department.
  • To qualify for this position the most suitable candidate must fulfill the following requirements.

Requirements

  • Minimum B.Sc. Degree in Chemistry or Equivalent Qualification in Chemistry
  • Good knowledge of chemistry (Analytical and Organic)
  • 1-3 years of experience in a pharmaceutical, GMP, or chemical manufacturing environment would be advantageous
  • Proven experience in the compilation of documents would be advantageous
  • Computer Literacy MS Office, i.e. Word, Excel, Outlook, Access, etc.

Skills & Competencies

  • Good interpersonal skills
  • Good organizational 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 critically evaluate data
  • Ability to perform tasks concurrently
  • Self-motivated

Responsibilities

  • Compilation and update of documents to be submitted to Regulatory Authorities. This includes a compilation of Common Technical Documents.
  • The compilation, update and/or amendment of internal documentation relating to testing, cleaning and manufacture instructions of APIs.
  • Compilation of process qualification protocols and reports.
  • Appropriate implementation of changes in accordance with company procedures relating to the testing and manufacturing process.
  • Investigating, evaluating, and reporting on process performance and changes.
  • Ensuring that annual product quality reviews are compiled according to GMP requirements and improvements identified.

Additional Information

  • Suitably qualified applicants are invited to submit their CV’s online on or before the specified date.
  • Preference will be given to applicants from designated groups in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate.
  • If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

Lo msebenzi uphelelwe. Closing date yawo ibi nge .

Lo msebenzi ufakwe ngu Tebuho Moshoeshoe nge 11 ka May 2022