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Responsible for supporting the 503b Outsourcing Facility for clinical and regulatory (FDA and State) compliance for product labeling essential copy assessments, review compounded sterile product Master Batch Records as part of new product introduction and working with both the operational and quality units to meet customer needs.
- Approval of initial CSP label specification and any changes that area potentially patient or product impacting.
- Approval of essential copy assessments to meet FDA 503Bb requirements.
- Approval of initial Master Batch record for new products as well as revisions of MBRs for major process changes.
- Support complaints and impact assessment in deviations as the patient advocate in the roll of Pharmacist.
- Support customer, FDA, and State inspections as Pharmacist-in-Charge.
- Support review of FDA biannual compounded Product Reporting.
- Obtain and maintain state pharmacy licenses, where required, and ensure site is up to date on state requirements.
- Perform periodic review of completed disposition packets to maintain a working knowledge of site activities related to products distributed.
- Support the controlled substance program, as needed.
- 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.
- Comply with relevant Acts, legal demands, code of conduct and ethical standards.
Distinguiti dagli altri
- Graduated from accredited college of pharmacy.
- Registered Pharmacist in the state which manufacturing will be done at minimum. Obtaining additional state licenses will be required, if not already completed.
- At minimum, on-site support for one week every two months or additionally as needed to support inspections.
- Previous experience in GMP cleanroom environments, strongly preferred.
- Experience in administration and/or hands-on responsibility for controlled substances, preferred.
- Additional Project Management and/or Process Improvement activities can be included with job, based on prior experience.
- Indirect oversight of on-site pharmacist may also be required.
- Computer skills, MS Word, MS Excel required.
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.