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QA MANAGER GMP/MD

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QA MANAGER GMP/MD

Camurus is a Swedish research-based pharmaceutical company committed to developing and commercializing innovative and long-acting medicines for the treatment of severe and chronic conditions, including opioid dependence, pain, cancer and endocrine disorders. New drug products are based on our proprietary FluidCrystal ® drug delivery technologies with the purpose to deliver improved quality of life, treatment outcomes and resource utilization. The company’s share is listed on Nasdaq Stockholm under the ticker “CAMX”. For more information, visit camurus.com. 

At Camurus you will get the opportunity to work with committed colleagues in a team with good atmosphere, where the employees support and care for each other. Camurus is an innovative company that is currently expanding and establishing in new markets. 

We are strengthening our Quality Unit and recruiting a 

QA Manager within GMP and MD (PRRC) 

In this position you will collaborate with our external contract manufacturing organizations (CMO), contract laboratories (CL) and suppliers providing both GMP and Medical Device (MD) support. You will be responsible for the Medical Device (MD) part of Camurus’ Quality Management System and for combination products. You will be the Person Responsible for Regulatory Compliance, PRRC, MD. 

You will be responsible for:  

  • Timely and high-quality deliverable from Quality Unit within GMP and MD area including collaboration externally with CMO, CL, Supplier’s quality functions and internally to other functions within the company. 

  • In relevant parts, responsible for assuring compliance for Quality Unit with the company’s quality management system and applicable policies, quality manual MD and standard operating procedures 

  • Ensure compliance with and provide guidance for GMP, MDD/MDR, ISO13485, QSR and other national standards applicable for the company’s quality management system 

  • Participate as Quality Units representative (GMP) in R&D Project Team(s) for company sponsored clinical trials and marketed medicinal product and interact with external counterparts 

  • Contribute to review and approve of CMO/CL MD/Pharma documents  
    such as: Quality agreements, Master batch records, Change controls, OOS, deviations and CAPAs, Stability protocols and reports, Process and method validation protocols and reports 

  • Preparing documents for PQR.  

  • Perform vendor qualification such as: GMP audits of CMOs, CLs and suppliers, establish and evaluate (GXP) vendor questionnaire, performance monitoring 

  • Contribute to the company’s internal audit program together with the other quality managers 

  • Review, write, approve, and implement SOPs  

Specific tasks for Medical Device/Combination product part of position are to: 

  • Act as PRRC as defined in MDR (EU) 2017/745 article 15 

  • Maintain Quality Manual MD 

  • Lead and prepare documents for Management Review Meetings  

  • Manage, coordinate, prepare and follow-up of external inspections for MD/Combination product, e.g. accredited body or authority inspections. 

  • Participate in MD/Combination product project team  

  • Handling of complaints and recalls and vigilance reporting.  

Candidate profile 

  • Academic degree within pharmacy, chemistry or microbiology 

  • GMP and MD professional experience: 

    • previous experience within GMP for example in pharmaceutical manufacturing or Quality Assurance 

    • previous experience in regulatory affairs or in quality management systems relating to medical devices 

  • Knowledge of applicable international standards and guidelines for Pharmaceuticals and Investigational Medicinal Products within GMP in EU, USA.  

  • Combination product (US)/Drug Device combination product (EU) 

  • Knowledge of applicable international standards and guidelines for Medical Devices   

  • Lead auditor experience within MD/GMP and/or experience as co-auditor  

To be successful in this position you have excellent oral and written communication skills and are fluent in oral and written English. We believe that you have a good systematic way of working and that you are structured and organized. To be a successful candidate you are an experienced user of MS Office and can manage different projects at the same time.  

The opportunity for you 

This is a great time to join a highly dynamic company during a very exciting phase of growth. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. 

Camurus has approximately 150 employees with the head office located in Lund. The corporate culture is driven by innovation, strong collaboration internally and externally, ownership, quality, and passion about realizing our ideas to achieve our patient-centric vision. 

This is an immediate, full-time employment opportunity. The application process is ongoing, so apply with your cv and cover letter as soon as possible. Please note that we do not accept applications by e-mail. For further information, contact Recruitment Consultant Björn Jonasson at Roi Rekrytering; bjorn.jonasson@roirekrytering.se

Read more about how Camurus will process your personal details here

 

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QA MANAGER GMP/MD

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