QA Pharmacist - East Anglia
Our client is a well-known pharmaceutical company engaged in the manufacturing of cutting edge healthcare products and treatments. They are actively seeking a QA Pharmacist to assist in the provision of compliant pharmacy services with cGMP and 'Specials' manufacturing requirements.
SUMMARY:
Ensuring compliance of Thetford Pharmacy Services with cGMP and "Specials" manufacturing requirements, as well as regulatory and Baxter Corporate expectations;
Providing QA technical support to the manufacture of aseptically prepared products (Total Parenteral Nutrition solutions, Cytotoxics and Antibiotics in "ready-to-use" containers), including reviewing of formulation and establishing product shelf life;
Providing expertise and training on the clinical background and pharmacological aspects of the products manufactured by Thetford Pharmacy Services;
Working in collaboration with the business and production in identifying and implementing new and business growth opportunities;
Working in collaboration with the other Baxter Compounding units in sharing best practices and standardising procedures;
JOB REQUIREMENTS:
Providing QA oversight to new product introduction, including establishing product shelf life, validating formulation and ensuring "Specials" regulatory requirements are met;
Providing QA oversight to product and process changes and validation;
Ensuring process deviations are adequately investigated and appropriate corrective and/or preventative actions are implemented;
Ensuring product complaints are adequately investigated and appropriate corrective and/or preventative actions are implemented;
Supporting and leading problem solving and continuous process improvement initiatives.
Education:
Degree in Pharmacy
Experience:
Breadth & Depth of experience: 3 years in similar role
Field of expertise: Quality Assurance, Aseptically prepared products, Specials manufacture
Key Words: Quality Assurance, Aseptically prepared products, Specials manufacture