Head of Quality Assurance

On behalf of our client Sinceritas, pharmaceutical company whose focus of operation is the cultivation and production of cannabis for medical purposes, DEKRA is looking for: 

• Head of Quality Assurance 

JOB DESCRIPTIONS: 

• Review, ensure compliance to the GMP and approve all SOPs; 
• Final batch review and release, including review of analytic and microbial results and facility conditions deviations and change controls; 
• Guide and advise Corrective and Preventive Actions (CAPA) review & approval; 
• Ensure Investigation & annual product review are conducted in a compliant matter;  
• Oversee the management of the Complaint program to ensure all critical trends are addressed appropriately and investigations are handled;  
• Oversee and direct raw material control system;  
•  Design and write SOPs that comply  with GMP; 
• GMP training of new and ongoing staff;  
• Efficiently and effectively make accurate assessments of failures to correct root cause to ensure continuous improvement; 
• Directly manage QA Team;  
• Provide guidance to all other areas of the facility with respect to GMP; 
• Involved in IMS (Integrated Management System);  
• Other responsibilities related to Quality Assurance Management programs and procedures, in accordance with candidate’s skills and qualifications. 

QUALIFICATIONS: 

• Minimum 5 years’ experience in the Quality Assurance Field; 
• A degree or diploma in science related field Chemistry, Biology, Pharmacy; 
• Experience in Drug or Natural Health Care product manufacturing environment; 
• Ability to implement and maintain a Quality Assurance System including: batch record review, batch release, document control and CAPA including quality investigations; 
• Fluency in MS Office is mandatory; 
• Competency of technological writing (SOP’s, annual reports, investigation summery etc.) 
• Ability to work independently, with a strong attention to detail; 
• Ability to speak and write in English. 

ADDITIONAL INFORMATION 

If you feel that you have the necessary experience and are interested in this opportunity, please send your CV in English on the following e-mail address: rabota.arbeit.mk@dekra.com 

All received applications will be considered in strict confidentiality. Only short-listed candidates will be contacted for an interview. 

*By sending your CV and motivation letter, you agree that your personal data will be processed for the needs of recruitment and selection by DEKRA Arbeit Macedonia and they will be stored in the DEKRA database. 

Note: Candidates can withdraw their permission to process their personal documents at any time by sending a notification to the e-mail: job.arbeit.mk@dekra.com