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Job Description
- Ensure that the organization’s Quality Management System conforms to customer, internal, and regulatory/legal requirements.
- Ensure evaluation of, and reporting on, vendor quality systems.
- Oversee inspection (examination) of incoming materials, ensuring that they meet requirements.
- Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products.
- Lead a team of Quality specialists, inspectors, auditors, analysts, and technicians
- Report to head of Supply Ops on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.
- Conduct periodic management review meetings.
- Oversee product recalls.
- Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices.
- Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality
- Formulate procedures to inspect and report quality assurance issues
- Monitoring all operations that affect quality
- Formulate procedures to inspect and report quality issues
- Monitor all operations that affect quality
- Assure the reliability and consistency of production by checking processes and final output
- Report all malfunctions to production executives to ensure immediate action
- Facilitate proactive solutions by collecting and analyzing quality data
- Review current standards and policies
- Keep records of quality reports, statistical reviews and relevant documentation
- Ensure all legal standards are met
- Communicate with external quality assurance officers during on-site inspections
- Determining, negotiating and agreeing on in-house quality procedures, standards and specifications
- Specifying quality requirements of raw materials with suppliers
- Investigating and setting standards for quality, health and safety
- Ensuring that manufacturing processes comply with standards at both national and international level
- Working with operating staff to establish procedures, standards, systems and procedures
- Writing management and technical reports.
- Determining training needs
- Acting as a catalyst for change and improvement in performance and quality
- Recording, analyzing and distributing statistical information
- Monitoring performance
Job Requirements
- BSc in pharmaceutical science, Biochemistry, Food processing or relevant field
- Certification of quality control is a strong advantage (ISO 9000 etc.)
- Proven +3 years’ experience as a quality control and assurance manager or 15 years combinations of relevant experience and knowledge may be substituted.
- Experience in the review and acceptance of material certification to ensure compliance with regulations and conformity to the specific supply contract requirements.
- Substantial experience in a manufacturing Quality Control role in pharma, food, or chemical industries.
- In depth understanding of medicine/food Safety and the quality control requirements, standards and specifications required for supply medicines/food.
- Thorough knowledge of methodologies of quality control & assurance and standards.
- Excellent numerical skills and understanding of data analysis/statistical methods Good knowledge of MS Office and databases.
- Excellent technical skills
- Good numerical skills and an understanding of statistics
- Leadership skills
- Planning and organization skills
- Communication and interpersonal skills
- Problem-solving skills
- Teamworking skills
- IT skills (ERP, SAP,..etc)