Aspen Jobs in Sandton – Regulatory Affairs Quality Pharmacist

Job Description:

To support the SA Commercial Business to realize the commercial strategy and to achieve the annual targeted growth and revenue through successful new product introductions and maintenance of current product portfolio in the South Africa and South African Development Community (SADC) region, by ensuring that the Quality aspects of all new Marketing Authorisations and variations from the SAHPRA and Regulatory Authorities of the SADC member states meet intended quality, safety and efficacy requirements as required of the MA Holder, within the committed timelines to ensure minimal disruption to launch and supply.

Job Responsibilities:

• Provide Quality support for the SA and SADC Supply Chain structure as it relates to Distribution and Wholesale matters.
• Conduct root cause analysis and risk assessments and reports
• To ensure company compliance with sound Quality Assurance principles, good manufacturing practice and regulatory requirements relating to the warehousing/distribution of medicines in South Africa
• Observing and complying with company Standard Operating Procedures (SOPs).
• Provide systems and SOPs implementation support for identified Woodmead Departments/Divisions.
• Keep abreast of developments in best practice, inspection trends and all QMS related activities
• Working with all members of staff to maintain and develop the positive progressive culture within Aspen.
• Observing and complying with Good Manufacturing Practice (GMP), Good Wholesaler Practice (GWP) and Good Distribution Practice (GDP).
• Interface with Pharmacovigilance, Medical Information, Regulatory and operational departments to ensure audit readiness at all times
• Active collaboration with the local Regulatory and Operations teams to ensure the appropriate flow of information and decisions
• Ensure compliance with Good Manufacturing Practices (cGMP), Good Storage Practices (GWP),Good Distribution Practice (GDP) as well as compliance with applicable local regulations.
• Active collaboration with the Regional and Global Product Quality team, to seek advice, inputs and guidance, and work on any regional or cross-functional projects.
• Any other duties as assigned by line manager / HOD

Job Requirements:

• Information seeking, effective problem solving and decision making
• An understanding of SADC and member states laws and regulations
• Intellectual curiosity – willing to suggest and try new ideas
• Comprehensive knowledge of SAHPRA and SADC Guidelines
• Sense of urgency – responding to issues and opportunities in a timely manner (Time management)
• The ability to communicate effectively (written and verbal) is essential
• Excellent interpersonal skills
• Results and performance driven
• Positive attitude and proactive approach to business tasks
• Experience with electronic quality management systems

Qualification & Experience:

• Registered with SAPC
• Matric
• Relevant Pharmacy Degree or equivalent
• Experience in Quality Management Systems required
• 3 to 5 years’ experience in Quality in a GxP-accredited pharmaceutical environment, preferably in an MA Holding, Distributor, Wholesaler or Manufacturing facility

Job Details:

Company: Aspen Pharma

Vacancy Type:  Full Time

Job Location: Sandton, Gauteng, SA

Application Deadline: N/A

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