Job Description

Requirements:

• 5-10 years experience in Pharmaceutical production environment in QA, QC, Validation and sterile manufacture.
• Relevant qualification will be advantageous.
• Extensive experience in inspections from SAHPRA.
• Excellent knowledge of regulatory affairs, statutory requirements on the pharmaceutical industry in South Africa.
• Excellent knowledge of best practices in technology transfer.
• Extensive problem solving and product research and development knowledge.

Responsibilities, but not limited to:

• Subject Matter Expert for the Technology Transfer processes in production, QC and QA departments with specific focus on regulatory, sterile manufacturing and validation.
• Responsible for leveraging and transferring own knowledge and expertise to the local teams in a systematic, structured, documented and auditable manner.
• To develop and maintain cooperative relationships with all regulatory bodies as well as in the maintenance of registration documents/applications/databases of all products in applicable countries.
• Ensure that local regulatory affairs unit applies latest procedures and guidelines as published.
• Responsible for ensuring that appropriate SOPs, protocol and reporting mechanism are in place for Regulatory portfolio, Technology Transfer and related processes.
• Support in the preparation of the site for audits and inspections, towards international competent authorities.
• Responsible to perform investigations in the area of responsibility.
• Conducts regular internal training of relevant Good Manufacturing Practices (GMP) and current industry practices.
• Responsible for being the single point of contact for Technology Transfer with the sales entity.

Kindly be advised that should you not receive a response within two weeks of applying, please consider you application unsuccessful.

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