Post Production Compliance Pharmacist

Who We Are

Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of the personalized medicine”. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.

About The Job

As a Compliance Pharmacist, you will be a responsible, servant leader who is methodical and goal-oriented to ensure that all compounding operations are performed in compliance with FDA regulations. One who operates according to Standard Operating Procedures within the quality system, all applicable state and federal pharmacy laws and the requirements of cGMP. Ensuring DEA and cGMP compliance by continuous review and auditing of facility operations. This role bridges the pharmacy operations and quality assurance to maintain regulatory compliance, oversee documentation practices and support audits, investigations and regulatory inspections.

Key Responsibilities

Operational:

• Hand hygiene/Garbing
• Weighing of ingredients, pH adjustments
• Proper cleaning
• Formulation, filling, visual inspection, labeling process assessment
• Training collaborations
• Evaluate current procedures/processes to identify areas of potential risk within the production operations and help develop strategies to mitigate these risks.
• Conduct training sessions for employees on compliance-related issues/topics
• Create and update SOPs to maintain compliance with regulatory standards
• Responsible for leading initiatives and tracking scrap reduction within the facility
  
  

Daily responsibilities:

• Monitor day-to-day compounding operations to ensure compliance with FDA 503B requirements and cGMP regulations.
• Perform regular internal audits and gap assessments of operations to identify potential compliance issues and assist with implementation of corrective actions as needed to maintain regulatory and cGMP compliance
  
  

Overall:

• Assist in developing, implementing, and maintaining training protocols that align with established media fills, smoke studies, and regulatory expectations.
• Evaluate current procedures/processes to identify areas of improvement, streamline operations and enhance productivity
• Review batch records, deviations, CAPAs, EM data for compliance risks
• Stay current on regulatory changes and other 483s/warning letters (FDA guidance, USP chapters, etc)
• Participate in regulatory audits as needed
  
  

Basic Qualifications

• Pharmacist License in good standing in the state of Kansas
• 2 years of experience working in a regulated environment
• Solid math and practical problem-solving skills with demonstrated use of sound judgement.
• Excellent attention to detail and documentation skills.
• Strong analytical, organizational, and communication abilities.
• Familiarity with quality management systems, deviation/CAPA systems, and audit processes.
• Ability to work cross-functionally in a fast-paced regulated environment.
• Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, and accountability.
  
  

What's on Offer?

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.

Ready for the challenge?

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.