Regulatory Compliance Specialist

18 hours ago


Pretoria, Gauteng, South Africa Department of Justice and Constitutional Development Full time
About Our Team:

We are a dynamic team of professionals dedicated to ensuring the highest level of quality and compliance in our pharmaceutical manufacturing operations. We are seeking a highly experienced Quality Assurance Pharmacist to join our team in Pretoria.

Key Responsibilities:

  • Develop and implement quality management systems and procedures
  • Conduct regular audits and inspections to ensure compliance with GMP and ISO9001
  • Collaborate with cross-functional teams to resolve quality-related issues
  • Analyze data to identify trends and areas for improvement
  • Develop and deliver training programs on cGMP and relevant SOPs
  • Lead and participate in risk assessments and validation activities
  • Coordinate and control the stability program
  • Perform annual product reviews and trend analysis
  • Draft and submit reports on quality performance
  • Administer continual improvement systems and lead/participate in CAPA/deviation investigations
  • Assist in conducting supplier and internal audits, preparing for audits by 3rd parties
  • Review new guidelines, outside inspection reports and current trends in GMP
  • Support project groups on projects, QA activities on new product development and new facilities


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