The Production Pharmacist is responsible for ensuring the quality, safety, and efficacy of pharmaceutical products manufactured in a production facility. He or She will oversee the production process, manage quality control, and ensure compliance with regulatory requirements.
Key Responsibilities:
Production Oversight: Supervise the production process, including batch manufacturing, filling, labeling, and packaging.
Quality Control: Implement and manage quality control procedures to ensure products meet regulatory and company standards.
Regulatory Compliance: Ensure compliance with relevant laws, regulations, and industry standards (e.g., GMP).
Batch Release: Review and approve batch records, certificates of analysis, and other documentation to ensure product quality and compliance.
Deviation Management: Investigate and address deviations, discrepancies, or complaints related to production.
Training and Development: Train production staff on procedures, policies, and regulations.
Documentation and Record-Keeping: Maintain accurate and complete records of production, quality control, and regulatory activities.
Continuous Improvement: Participate in quality improvement initiatives and implement changes to optimize production processes.
Audits and Inspections: Assist with internal audits, regulatory inspections, and customer audits.
Communication: Collaborate with cross-functional teams, including quality assurance, research and development, and regulatory affairs.
Requirements:
Education: Bachelor’s or advanced degree in Pharmacy (B.Pharm, M.Pharm, or PharmD).
Licensure: Current registration as a pharmacist in the country/state of practice.
Experience: Minimum 2-5 years of experience in pharmaceutical manufacturing, quality control, or regulatory affairs.
Knowledge: Strong understanding of GMP, regulatory requirements, and pharmaceutical production processes.
Skills: Excellent communication, leadership, and problem-solving skills.
