Tabuk Pharmaceuticals -
السعودية , Dammam
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Tabuk Pharmaceuticals

تفاصيل الوظيفة


  • Implement and review departmental Standard Operating Procedures (SOPs) for all production activities, ensuring compliance with internal standards and regulatory guidelines.

  • Provide line clearance for production activities, ensuring all areas are prepared for the next batch and meet required standards.

  • Review and approve sampling protocols for finished products, intermediates, in-process materials, stability samples, cleaning validation samples, verification samples, and reserve samples as per defined protocols.

  • Approve packaging materials specimens to be attached with Packaging Order Instructions (POIs) and ensure they meet compliance standards.

  • Check manufacturing and packaging POIs in the production area to ensure compliance with quality standards and regulatory requirements.

  • Inspect finished goods and authorize their release for dispatch or recommend rejection based on adherence to quality standards.

  • Affix Release and Rejection labels provided by QC for product batches at various stages of manufacturing.

  • Highlight and escalate quality-related problems, ensuring thorough investigation and resolution.

  • Lead root cause analysis and implement corrective and preventive actions (CAPA).

  • Ensure compliance with documentation systems, ensuring accurate record-keeping and alignment with cGMP requirements throughout production activities.

  • Manage non-conforming products by initiating actions, including rejection for investigation, rejection for destruction, or addressing out-of-specification issues.

  • Conduct cGMP checks in the production department to ensure adherence to Good Manufacturing Practices and lead internal audits for continuous compliance.

  • Develop and deliver training programs on related QA SOPs and cGMP practices for staff.

  • Identify specific training needs and arrange technical training courses to enhance professional skills and regulatory knowledge.

  • Collaborate with other departments (Production, QC, and Regulatory Affairs) to ensure alignment and compliance with quality standards and procedures.

  • Contribute to process improvements by identifying inefficiencies or areas of risk and recommending corrective actions.




  • Bachelor’s Degree in Pharmacy, Science, Medicine, Chemistry, or a related field.

  • Minimum of (3-6) years of experience in a Quality Assurance role within the pharmaceutical industry.

  • Experience in conducting cGMP audits, training staff, and ensuring compliance in production environments.

  • Experience with regulatory audits (e.g., FDA, EMA) and maintaining audit readiness.

  • Strong knowledge of cGMP (Current Good Manufacturing Practices) and pharmaceutical manufacturing standards.

  • Strong attention to detail and ability to work accurately under pressure.

  • Ability to work effectively in a team and across departments to achieve organizational quality goals.

  • Strong problem-solving and decision-making skills.

  • Ability to handle confidential and sensitive information with integrity.

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السعودية, Dammam