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Du er her:
Hjem - Quality Assurance Pharmacist

Quality Assurance Pharmacist

Quality Assurance Pharmacist
Udefinereret

Make your mark. Be part of an exciting journey!

Medican is committed to hiring individuals with a “can do” and positive attitude with willingness to learn and improve on skills and knowledge. 
We are looking for an individual with excellent interpersonal and communication skills.

The Position:
As a Medican Quality Assurance Pharmacist, you will be ensuring that Medical Cannabis Products comply with the local and international Quality Assurance standards, safeguarding legal compliance to these and thereby ensuring the quality assurance function in totality.  

Key responsibilities:

  • Ensure adherence to the Medican Quality system and Danish/ international requirements when executing quality activities
  • Act as QP deputy / delegate for release of commercial product batches to the designated market timeously and in line with requirements 
  • Participate in SOP writing/review
  • Support CAPA review, assessment, and closure as needed
  • Prepare training materials and conduct training when required
  • Provide QA oversight for QC labs
  • Investigate and manage Quality Events/Investigations to determine root cause
  • Assist with oversight of outsourced GMP/GDP relevant suppliers by ensuring that Quality Agreements are current, and audits are performed
  • Review and address any discrepancies and action corrective and preventative measures and any audit findings to ensure continual improvement.
  • Perform quality risk assessments, establish risk controls and review risks to assist with the Quality Risk management process and ensure that all GMP related documentation is handled correctly and is readily available
  • Handle complaints, recalls and returns in line with agreed processes and compile annual quality product reviews
  • Interact and support the relevant internal and external stakeholders with regards to ensuring quality standards and procedures are met and followed.
  • Perform any other tasks as requested by Management to support Quality oversight activities

Skills and Knowledge: 

  • Knowledge of relevant pharmaceutical and medicines legislation
  • Expert knowledge of Quality System and QA principles, practices and standards for the pharmaceutical industry
  • Good knowledge and understanding of cGMP, compliance and critical process parameters 
  • Knowledge of GDP. GACP will be a plus
  • Knowledge on validation.
  • Demonstrated ability to solve problems with an innovative mindset
  • Self-motivated and achievement driven as well as demonstrating accuracy and attention to detail
  • Ability to work cross functionally across teams and with multiple stakeholders
  • Technically independent to perform assigned task
  • Support in gathering and analyzing data for Discrepancy Trending
  • Identify, design and implement process and system improvements

The ideal candidate:

  • Pharmacy degree with +5 years’ experience as QA professional in the pharmaceutical quality assurance environment
  • Excellent interpersonal skills and great team player
  • Demonstrate excellent verbal and written communication skills in Danish and English
  • Quick learner with an open mind, receptive to change
  • Displays good level of problem solving ability and provide suggestion/alternative solutions on complex issues resolution
  • Manages deliverables effectively
  • Solid understanding of the technical process and workflow of daily job activities
  • Possess a systematic, analytical mind set, with an attention to details

Together we believe that embracing flexibility is a smarter way of working. Excellent journey starts here, apply now 

We encourage you to send your application and CV immediately to career@medican.com. Please mark your application "Quality Assurance Pharmacist". For further information, please contact Farzad Jahanshahi at +45 26132550.
 

 

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