Education
Pharm-D from a recognized university, preferably with BPS Certification in Compounded Sterile Preparations (CSP), MBA in Hospital and Healthcare Management, or additional specialized training in sterile and non-sterile compounding.
Job Description
Job Purpose:
To oversee and manage sterile and non-sterile (extemporaneous) compounding services, ensuring safe, accurate, and timely preparation of compounded medications in compliance with institutional policies, regulatory requirements, and internationally recognized standards, particularly USP <797> and USP <800>.
Job Responsibilities:
- Manage and supervise daily sterile and non-sterile compounding operations.
- Oversee preparation of IV admixtures, parenteral preparations, and other sterile pharmaceutical products.
- Supervise non-sterile extemporaneous preparations, including oral liquids, suspensions, topical formulations, and customized dosage forms.
- Ensure compliance with USP <797> and USP <800> standards and applicable regulatory requirements.
- Monitor cleanroom operations, aseptic techniques, environmental conditions, and contamination control practices.
- Ensure appropriate handling and preparation of hazardous drugs and compliance with hazardous drug safety requirements.
- Develop, implement, and review SOPs, master formulation records, compounding logs, and quality assurance procedures.
- Ensure appropriate formulation calculations, ingredient selection, stability considerations, beyond-use dating (BUD), and storage conditions.
- Oversee environmental monitoring, cleaning schedules, equipment qualification, and maintenance of compounding facilities.
- Conduct regular audits, risk assessments, and quality reviews to ensure compliance with established standards.
- Investigate compounding errors, deviations, and contamination incidents and implement corrective and preventive actions (CAPA).
- Develop and conduct training programs and competency assessments for pharmacists and pharmacy technicians involved in compounding.
- Monitor operational performance, productivity, turnaround time, and compounding-related wastage.
- Coordinate with clinical teams to ensure timely availability and appropriate utilization of compounded medications.
- Lead continuous quality improvement initiatives to enhance patient safety and operational efficiency.
Eligibility Criteria:
Essential Qualifications:
- Pharm-D from a recognized university.
- Minimum five (5) years of relevant professional experience in hospital pharmacy services.
- Demonstrated hands-on experience in both sterile and non-sterile (extemporaneous) compounding.
- Strong working knowledge of USP <797> and USP <800>.
- Practical understanding of aseptic techniques, cleanroom operations, environmental monitoring, and hazardous drug handling.
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- Experience in compounding quality assurance, documentation, SOP implementation, and regulatory compliance.
Preferred Qualifications:
- Board of Pharmacy Specialties (BPS) certification in Compounded Sterile Preparations (CSP) will be preferred.
- MBA in Hospital and Healthcare Management will be an added advantage.
- Additional certifications or specialized training in sterile and non-sterile compounding will be preferred.
Core Competencies:
- Technical expertise in sterile and non-sterile compounding.
- Quality assurance and regulatory compliance.
- Medication safety and risk management.
- Staff supervision, training, and competency development.
- Operational planning and management.
- Analytical, problem-solving, and decision-making skills.
- Effective communication and interdisciplinary coordination.