Responsible for ensuring the compounding unit is in compliance with all product labeling, essential copy policies, and creation of Master Batch Records for new products and major process changes. Key accountabilities include continuous improvement, administration, knowledge and compliance, and production compounding.
- Approval of initial CSP label specification and any potentially patient impacting changes.
- Approval of essential copy justifications during new product introduction.
- Approval of initial Master Batch record for new products.
- As needed, write SOPs, train employees and get a new controlled substance program started.
- Support deviations as the patient advocate in the roll of Pharmacist.
- Contribute improvement ideas and suggestions.
- Maintain a current and comprehensive knowledge of relevant procedures and policies.
- Attend relevant industry conferences to expand knowledge of relevant therapeutic areas.
- Understand the issues affecting the customers who prescribe our products and patients who use them.
- Compliance with relevant Acts, Legal Demands, Cod of Conduct, and ethical standards.
- Graduated from accredited college of pharmacy or foreign equivalent.
- Registered Pharmacist in the state which manufacturing will be performed.
- 3-5 years deep admixture experience.
- Experience in administration and/or hands-on responsibility for controlled substances.
- Previous experience in GMP cleanroom environments and/or advanced hospital IV admixture program strongly preferred.
- Computer skills MS Word, MS Excel preferred.
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.