တိုင်ကြားမှု အောင်မြင်ပါသည်

Key Responsibilities

1. Production & Compounding

• Oversee and perform sterile (IV) and non-sterile compounding and other specialty formulations.
• Ensure batch records, formulas, and SOPs are followed precisely.
• Manage preparation, labeling, packaging, and dispensing of products.
• Operate and maintain automated compounding equipment, laminar airflow hoods, isolators, and other production tools.

2. Product Development & Formulation

• Research & Design: Develop, validate, and scale-up formulations for sterile (e.g., IV bags, syringes, ophthalmic) and non-sterile (e.g., creams, gel, suspensions, capsules) compounded medications.
• Stability & Compatibility: Determine beyond-use dates (BUDs) based on physicochemical stability studies, sterility considerations, and literature references (e.g., stability references). Assess drug-drug and drug-container compatibilities.
• Master Formulation Record (MFR) Creation: Author and maintain definitive Master Formulation Records detailing:
  • Qualitative      and      quantitative     composition             (exact weights,           measures, calculations).
  • Specific ingredients (grades, sources). o        Step-by-step compounding procedures with critical process parameters. o   Required equipment and containers/closures.
  • In-process and final product quality control specifications (pH, osmolality, weight, sterility, endotoxin testing).
• Documentation: Maintain a formulation database and ensure all developed recipes are properly documented, approved, and archived

3. Production, Compounding & Scaling

• Execute compounding based on approved formulations, ensuring precise adherence to MFRs.
• Scale laboratory-based formulations to batch production sizes while maintaining stability, sterility, and homogeneity.
• Troubleshoot formulation and process issues during production (e.g., precipitation, pH drift, viscosity changes).

4. Quality Assurance & Compliance

• Implement and enforce quality control procedures for all products.
• Perform and document environmental monitoring.
• Conduct routine inspections of cleanrooms, equipment, and materials.
• Oversee end-product testing and sterility assurance.

5. Documentation & Record Keeping

• Maintain accurate batch records, compounding logs, and quality assurance documentation.
• Review and approve production records for completeness and compliance.
• Manage documentation for recalls, deviations, and corrective actions (Corrective Action and Preventive Action).

6. Inventory & Supply Management

• Monitor and order pharmaceuticals, supplies, and raw materials for production.
• Ensure proper storage and handling of ingredients, especially controlled substances and hazardous materials.
• Coordinate with purchasing and inventory teams to avoid shortages.

7. Staff Training & Supervision

• Train and supervise pharmacy technicians, interns, and support staff in aseptic technique and production procedures.
• Schedule and allocate staff for production workflows.
• Conduct competency assessments and ongoing education.

8. Safety & Risk Management

• Enforce safety protocols for handling hazardous drugs (HDs) and hazardous materials.  Ensure use of appropriate personal protective equipment (PPE) and engineering controls.
• Investigate and report adverse events, errors, or quality issues.

9. Process Improvement

• Optimize production workflows for efficiency and accuracy.
• Evaluate and implement new technologies, equipment, or formulations.
• Participate in continuous quality improvement (CQI) initiatives.

Education & Licensure

• Pharma degree from an accredited school.
• Current, active pharmacist license in the state of practice.
• Other certificate which is relevant to Pharmacist – preferred

Experience:

• Minimum 2–3 years of experience in pharmacy production, sterile compounding, or pharmaceutical manufacturing. (New Comer also welcome).
• Experience in a hospital, specialty pharmacy
• Familiarity with pharmacy management software.