Regulatory Affairs Pharmacist

2 weeks ago


Port Elizabeth, South Africa Fresenius Kabi Full time

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide. We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do. The manufacturing plant in Port Elizabeth produces both small and large volume parenterals. **_ General Duties:_** - Maintaining existing product registrations in foreign countries. - Responding to any deficiency letters or requests for information from the foreign countries. - Checking of printed packaging specifications and proofs relevant to these registrations. - Provision of product registration information on request by the Site Responsible Pharmacist and Export Marketing Managers. - Assisting the Export Marketing Department with tender information relevant to the company. - Preparing documents for international company registration in various territories. - Maintaining the international registration product list. - Assist with Batch Release when necessary - From time to time, carry out other jobs within the factory /department, consistent with the grade qualification and training of the incumbent. - B. Pharm / Dip. Pharm. - Registered Pharmacist with South African Pharmacy Council. - 2-5 years Industrial Pharmaceutical Regulatory Affairs experience - GMP, GWP and GDP Principles - Understand quality investigation requirements (risk assessments, deviations, OOS, change controls)



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