Raw and Packaging Materials Junior Manager Jamjoom Pharma  

Key Responsibilities:

• Review and Compliance:
• Review Standard Operating Procedures (SOPs) related to raw and packaging materials.
• Ensure compliance with Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) within the laboratory.
• Maintain a solid controlled documentation system for QC (raw and packaging materials).
• Review, validate and verify raw material test methods,
• Review analytical raw data, audit trails, Certificates of Analysis (COAs), and relevant data.
• Review sampling and receiving of raw and packaging material samples for analysis.
• Analytical Oversight:
• Perform and supervise the chemical and physical analysis of raw and packaging materials according to standard test methods and specifications.
• Perform daily reviews of instruments, equipment logs, and analytical results.
• Check and ensure timely release of raw materials based on analytical results.
• Investigate and report deviations, out-of-specification results, and any quality concerns.
• Team Management & Training:
• Plan, organize, and supervise the workload in the raw and packaging materials team to meet production needs.
• Train and mentor raw and packaging materials staff on analytical methods, SOPs, documentation practices, and safety protocols.
• Oversee the training needs, plans, and records for all personnel working with raw materials and packaging.
• Conduct performance evaluations for staff under responsibility.
• Raw Material and Packaging Management:
• Oversee the sampling, receipt, and analysis of raw materials, ensuring proper documentation and compliance with SOPs.
• Supervise the preparation of volumetric solutions, reagents, and chemicals for analysis.
• Review the reference materials and volumetric solutions standardization.
• Ensure implementation of the raw materials retesting plans.
• Manage the ordering of required reference standards (Primary, CRM) based on the needs of other QC lab departments and regulatory requirements.
• Review stocks of lab reagents periodically and ensure the availability of required reagents stocks.
• Documentation & Reporting:
• Review and sign documents related to starting (raw and packaging) materials analysis, standardization data, and analytical reports.
• Maintain accurate records of starting (raw and packaging) materials testing, equipment calibration, and reagents used.
• Write and update specifications for starting materials based on pharmacopoeias and regulatory standards.
• Issue Non-Conformance Reports (NCRs) and Out-of-Specification (OOS) reports when necessary.
• Quality & Supplier Evaluation:
• Evaluate the technical performance of equipment and suppliers of critical consumables, supplies, and services.
• Review purchasing documents for technical content prior to release.
• Monitor and report on the quality of raw packaging materials.
• Safety & Lab Environment
• Enforce safety protocols and PPE usage
• Promote a clean, compliant, and efficient laboratory environment.