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We are it again , My client based in Cape Town is looking for an Astute Assurance Manager with the following
Key Responsibilities:
* Supervise and train personnel involved in quality assurance processes.
* Ensure that all equipment/instruments are appropriately maintained.
* Ensure monitoring of pharmaceutical environment
* Ensure performance of appropriate process and method validations
* Conduct internal audits and compile audit reports
* Drive continuous process improvement efforts
* Ensure thorough investigations, determine root cause and ensure the relevant corrective action in a timely manner
* Complete and control records related to Quality Assurance functions
* Manage QA staff to ensure tasks are completed to specified standards & within required time limits
Key Requirements:
Qualification:
B Pharm
Registered as a qualified pharmacist with the South African Pharmacy Council.
Experience:
* Three years CGMP experience gained at an internationally recognised pharmaceutical company
* Experience in the requirements of drug registration and compilation of Drug Master Files (DMFs).
* Experience in method and process validation.
* Compliance auditing experience
* Quality control and quality assurance experience in a radiopharmaceutical manufacturing environment
Knowledge:
* Sound knowledge and understanding of all relevant legislation and regulations.
* Familiarity with radiopharmaceutical manufacturing processes and related QC release testing.
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