Description

• Implement, communicate and maintain Company’s quality systems and policies at the facility, in compliance with Marken’s Global quality management system requirements and local requirements.
• Effectively interact with other Marken department and stake holders to maintain quality and
• help introduce new quality improvements.
• Agree standards and define quality processes and procedures through effective controlled document issue and management.
• Interact with clients on Quality Assurance (QA)/ GxP related matters.
• Write quality assurance procedures as required for GxP Compliance.
• Participate and monitor the internal audit schedule and perform/ or delegate, including report preparation, assessment and tracking of associated corrective and preventive actions (CAPA). To ensure that a self-inspection audit is done once a year in the local Marken facilities.
• Maintain the vendor qualification program, this includes, but it is not limited to the QTA (Quality Technical Agreements) updates and performing Quality audits.
• Host client audits and regulatory inspections, manage the audit report responses and act as Marken’s main representative, including and preparing of appropriate materials required within those audits when applicable.
• Manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives.
• Identify relevant GxP/ Quality related training needs and deliver or make they are deliver where required.
• Maintain the oversight of review and release of incoming material receipts in   accordance with product specification where applicable.
• Perform QA role in qualification/validation activities.
• Manage/Approve the change control.
• Prepare and acquire appropriate data to complete trending and KPI reporting requirements.
• Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed.
• Hires and trains quality assurance staff. 
• Oversees the daily workflow and schedules of the department.  
• Conducts performance evaluations that are timely and constructive.  
• Handles discipline and termination of employees in accordance with company policy. 
• Ensure timely and efficient management of records pertaining to the Quality Assurance Team.

• Bachelor’s degree
• Minimum 5 years of relevant experience working in a Quality Assurance role within a GSP/GMP/GDP regulated position.
• Knowledge of Good Manufacturing Practice, Good Storage Practice and Good Distribution Practice guidelines.
• Knowledge of local regulations.
• Previous experience in Quality Management Systems with an eye for details.
• Excellent written and oral communication skills.
• Good interpersonal skills
• Organized, methodical and efficient approach to work.
• Proficient use of Microsoft Office