Quality Assurance Specialist

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Job Description:

Job Summary

The Quality Assurance Specialist is responsible for supporting the QA Supervisor with the oversight and implementation of the Marken Quality Management System (QMS), Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation, Kit Production Facility.

The QAS also needs to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001.

Responsibilities:

• Implement, communicate and maintain the company’s quality systems at the facility, in compliance with Marken’s Global Quality Management System (QMS) requirements.
• Interact with clients on Quality Assurance (QA)/ GxP related matters.
• Effectively interact with Departments and stakeholders to maintain that all QA tasks are appropriately supported by QA.
• Oversee an internal audit schedule and perform internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA).
• Perform audits of external service providers as part of the vendor selection process. Tracking and overseeing all commitments for actions or changes made from previous audits.
• Support client audits and regulatory inspections, including and preparing appropriate materials required within those audits when applicable. Support the audit report responses and act as main representative when aligned with QA Supervisor.
• Work and manage issues and CAPA plans, collate CAPA metrics, and identify and implement quality improvement initiatives. Oversee activities that conclude on the appropriate close-out of all CAPA entries.
• Identify relevant GxP/ Quality related training needs and deliver or ensure they will be delivered when required.
• Support on change control management.
• Ensuring that the Quality System and GxP Program are implemented and maintained.
• Assisting in the evaluation of designated vendors and/or out-sourced activities.
• Ensuring the accuracy and quality of records and documents.
• Monitor that training for all personnel is conducted and documented.
• Coordinating and promptly performing any recall activity.
• Participate actively in all the internal Quality and/ or designated meetings.
• Keep informed of regulatory changes in Country/Region and prompt updates to SOPs as needed.
• To execute qualification activities and oversee calibration related to devices, equipment, systems and facility in SAO branches.
• Ensure that the facility is working according to local laws and authority regulations

Qualifications:

• Pharmaceutical or healthcare industry experience;
• Bachelor’s Degree in Science related field (or internationally comparable degree) required;
• Knowledge of Good Manufacturing Practice, Good Sorage 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;
• Advanced English communication;

Employee Type:
 

Permanent

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