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Job Description
- Oversee all QC operations, ensuring compliance with ISO 17025 and GLP standards.
- Review and authorize quality control documentation, including SOPs, testing methods, and analysis results, while ensuring conformity to standards.
- Approve or reject raw materials, packaging, and finished product certificates (COAs).
- Supervise the monitoring and control of manufacturing environments and water systems.
- Manage investigations into out-of-specification (OOS) or out-of-trend (OOT) results, reducing errors in laboratory processes.
- Plan and execute training programs for QC staff, ensuring skills are updated to meet organizational needs.
- Supervise the validation and transfer of analytical methods while ensuring corrective and preventive actions are implemented.
- Maintain proper documentation and storage of retention samples, reference standards, and working standards.
- Collaborate on customer complaint investigations and implement effective resolutions.
- Approve contracts with laboratory equipment suppliers and oversee procurement processes.
- Establish departmental objectives in line with the company’s strategic goals and ensure employees are aware of these objectives.
- Regularly update testing protocols, organizational charts, and departmental structures to meet operational needs.
- Promote a safe, compliant, and innovative work culture across the QC team.
Job Requirements
- Bachelor degree of Pharmaceutical science.
- +10 years of experience in well-known know Pharma companies.
- Comprehensive knowledge of analytical techniques, microbiology, and chemical testing processes.
- Strong familiarity with EU, EDA, WHO, and FDA GMP regulations.
- Proven leadership capabilities, strong decision-making skills, and reliability.
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