Job Description

Eastern Cape, Port Elizabeth

Monthly Cost To Company (Market related)

Our client, in the Pharmaceutical Manufacturing Industry, based in Port Elizabeth is currently looking to employ a Technology Transfer Manager.

Job overview:
To enhance and optimize the regulatory portfolio by strategically analyzing the files with regards to but not limited to harmonization, suppliers, batch size, specifications, test methods etc., in cooperation with planning, production, QC, Market Unit and other stakeholders. Assume overall responsibility as SME and for Technology Transfer project coordination at the Plant.

An awesome career opportunity awaits!

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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