What are the responsibilities and job description for the Compounding Pharmacist position at Aveva Drug Delivery Systems?
Key Responsibilities:
Production Oversight:
- Directly supervise and oversee 503(b) compounding operations, including aseptic processing and terminal sterilization activities.
- Ensure adherence to batch production records (BPRs) and standard operating procedures (SOPs).
- Monitor production activities to maintain compliance with cGMP, FDA 503(b) outsourcing facility regulations, and State of Florida pharmacy board requirements.
Regulatory Compliance:
- Ensure all operations comply with applicable state and federal pharmacy laws and FDA regulations.
- Maintain the pharmacy license and ensure all processes meet Florida Board of Pharmacy standards.
- Conduct regular documentation reviews and approve production batch records to ensure completeness and accuracy.
Quality Assurance:
- Collaborate with the Quality Assurance (QA) team to ensure that compounded and terminally sterilized pharmaceuticals meet quality and safety standards.
- Participate in quality investigations, deviations, corrective and preventive actions (CAPAs), and audits.
- Support validation activities, including aseptic process simulations (media fills) and sterilization process validations.
Team Leadership and Training:
- Provide leadership, training, and technical support to compounding technicians and other personnel.
- Ensure all staff are trained and competent to perform duties in compliance with GMP and regulatory requirements.
- Foster a culture of continuous improvement, safety, and quality.
Operational Responsibilities:
- Monitor and ensure accurate labeling, documentation, and traceability of compounded products.
- Collaborate with supply chain and production teams to manage inventory of raw materials, consumables, and sterile components.
- Assist with process improvements to optimize production efficiency while maintaining compliance and quality standards.
Qualifications:
Education:
Bachelor’s or Doctor of Pharmacy (PharmD) degree from an accredited institution.
Licensure:
Must hold an active Registered Pharmacist license in the State of Florida.
Experience:
- Minimum of 3 years of experience in pharmaceutical compounding or sterile manufacturing.
- Experience with 503(b) outsourcing facilities and aseptic/terminal sterilization processes preferred.
Knowledge:
- Strong understanding of cGMP, 503(b) outsourcing regulations, FDA guidelines, and aseptic/sterile compounding principles.
- Familiarity with environmental monitoring, gowning, and aseptic techniques in controlled manufacturing environments.
Skills:
- Excellent organizational, communication, and leadership skills.
- Proficiency in reviewing and maintaining documentation, including batch records and SOPs.
- Strong problem-solving skills and attention to detail.
Work Environment:
- Work is performed in a cleanroom environment that requires appropriate aseptic gowning and adherence to strict aseptic protocols.
- May require extended periods of standing, walking, or lifting in a production setting.
- Regular interaction with production equipment and materials in sterile and controlled environments.
