Job Description
Key Accountabilities and Decision Ownership:
- Process Oversight and Supervision: Supervise manufacturing unit operations (e.g., dispensing, blending, compression, filling, etc.) to ensure they are performed according to the batch record and SOPs. Provide scientific and pharmaceutical guidance to the production team.
- Technical Problem Solving: Act as a subject matter expert to resolve day-to-day process and equipment problems. Investigate issues related to material properties, formulation behavior, or equipment malfunction from a scientific perspective.
- Deviation Investigation: Contribute to the investigation of process deviations. Analyze the potential impact on product quality and assist in determining the root cause and appropriate CAPAs.
- Batch Record Review and Approval: Perform real-time and final review of executed batch records, ensuring all steps are completed correctly, all data is accurate, and any deviations are properly documented before the batch is forwarded to QA.
- Training and Development: Provide effective training to production staff on pharmaceutical principles, cGMP requirements, and specific process SOPs. Ensure the team understands the “why” behind the procedures.
- Process Improvement and Validation: Assist in the development, modification, and validation of pharmaceutical processes. Participate in technology transfer activities for new products, providing input on manufacturability.
- Material Management: Ensure the correct handling, storage, and use of raw materials, intermediates, and active pharmaceutical ingredients (APIs) throughout the manufacturing process.
Must have technical / professional qualifications + (knowledge & Skills level of presence in the job):
Academic, technical, and professional qualifications:
- Essential: Bachelor’s Degree in Pharmacy or Chemistry.
Experience:
- Essential: 0-2 years of experience for Pharmacist level; 2+ years for Senior Pharmacist, preferably in a pharmaceutical manufacturing environment.
- Desirable: Supervisory experience in a GMP environment is an advantage.