Qualified person

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: 

• Qualified person        

JOB DESCPRITION: 

• Acts independently in taking quality decisions; 
• Thorough understanding of pharmaceutical law, quality management systems and the professional duties of a QP; 
• Technical pharmaceutical knowledge or medicinal chemistry knowledge; 
• A strong understanding of the manufacture and supply chain; 
• Responsible for the QP certification of Drug Products; 
• Acting as a point of contact for queries relating to QP certification and batch release; 
• Ensures the operations according to GMP compliant manner in accordance with all the relevant legislation, corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the products and processes are fully compliant with the filed regulatory dossiers for the products supported; 
• Actively participates in preparation for GMP inspections, other controls and audits; 
• Actively works in the implementation of ISO 17025; 
• Actively works in the Integrated Software (ERP); 
•  Ensure that the required initial and continuing training of  the department personnel
  is carried out and adapted according to need; 
•  Ensure qualification and maintenance of  the department, premises and equipment; 
•  Ensure that the appropriate validations are done; 
• Ensures implementation of all necessary tests and evaluation of the obtained results; 
•  Approve or reject starting materials, packaging materials, intermediate, bulk and finished products; 
•  Approve and monitor the employees; 
•  Approve specifications, sampling instructions, test methods and other Quality Control procedures; 
• Evaluation of the complete production and analytical file; 
• Participation in IMS (Integrated Management System) integration; 
• Other responsibilities related to candidate’s skills and qualifications relevant for the position; 
• Management of the Quality Assurance System. 

QUALIFICATIONS: 

• Bachelor’s Degree in Pharmacy and Specialization in Drug Control or Specialization in Pharmaceutical Technology; 
• At least 5 years’ experience in pharmaceutical manufacturing either in a QA or QC role; 
• At least 5 years supervisory or management experience desirable; 
• Excellent leadership skills; 
• Ability to cope well under pressure, make confident judgements and act decisively; 
• Extensive experience in conduction and maintaining quality management systems (GMP, ISO); 
• Good command of written and spoken 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