About the job
The primary responsibility of the Pharmacist in Charge is to ensure adherence to facility SOP’s and procedures, adherence to state and federal regulations, and directly supervise pharmacists. The PIC will work directly with Aseptic Operations Manager to ensure production goals are achieved, assist with investigations, assist in daily operational pharmacy duties, monitor training and work with training/compliance team to ensure all training is up to date.
Under indirect supervision, oversees all aspects of the pharmacy operations. Assures that all services comply with professional standards and applicable laws. Exercises broad judgment in professional field requiring extensive subject matter knowledge and expertise, while keeping senior leadership fully informed of operating issues and results
- Responsible for the execution of opening and closing activities; either directly, or through delegation to a staff pharmacist. Ensuring that strict procedures are followed around the facility.
- Represent the facility in all state and federal regulatory audits, visits, and communication.
- Directly supervise staff pharmacists.
- Work with Clean Room Operations Manager to ensure production goals are created, tracked, and met. Identify trends or issues that are delaying batch production or causing batches to be cancelled.
- Writing operational and production SOP’s.
- Liaison with the quality department.
- Maintain compliance with all state and federal regulatory agencies.
- Assist in documentation and completion of Adverse Drug Event forms.
- Answer clinical questions from health professionals and provide product information.
- Support order verification within computer order processing queue to ensure facility and product accuracy.
- Review of all batch records and associated documentation verification.
- Ensuring safe work environments, enforcing operational discipline, and monitoring aseptic behaviors.
- Efficiently utilize tools and metrics (KPI’s) to monitor staff productivity, deliverables, timelines, and quality of work product to adjust staffing levels and operational processes as needed to ensure operational effectiveness.
- Understanding of the importance/impact of cGMP standards.
- Maintain state pharmacy license(s).
Set yourself apart
You possess the following qualifications, background and abilities:
- The Pharmacist in Charge shall maintain at all times a pharmacist license in the state of Kansas that is in good standing and current. Obtaining licensure in other states may be required to fulfill state specific regulatory obligations
- 5-8 years pharmacy experience and a good understanding of quality and compliance requirements pertaining to cGMP and 21 CFR 210 & 211. Prefer experience with a manufacturing environment.
- 2-5 years management experience; with no fewer than 3 direct/indirect reports.
- Proven effective verbal and written communication skills
- Experience working with standard ERP/MRP systems.
- Experience interpreting compliance requirements and regulations is required.
- Knowledge of DEA, FDA and state regulations pertaining to manufacturing and handling of controlled substances.
- Capable of lifting up to 50 pounds, standing for extended periods of time and shall have no allergies to chemicals that might be used during compounding.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
- Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
- Able to establish robust processes, develop performance standards, track performance through fact driven exercises, and implement solutions to drive continuous process improvements.
- Demonstrates skills to solve complex problems in a wide variety of high pressure situations which require a high degree of ingenuity, creativity and innovativeness. In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution and take action.
- Demonstrates a strong ability to be adaptable and flexible.
- Demonstrates proven knowledge of business and management principles.
- Previous experience working with auditors, inspectors, and regulatory agencies.
- Previous experience operating under FDA cGMP with a robust understanding of the principles and applications associated with manufacturing operations.
What’s on offer?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.