QA/RA Manager

vor 1 Monat

Munich, Deutschland Flavine Vollzeit

Join our team in Munich, Germany, and step into the role of QA/RA, where you'll play a pivotal role within our vibrant QA/RA department, with the focus on API. This position isn't just about day-to-day operations; it's about spearheading the enhancement of our QA/RA operational system to boost the efficiency of our entire department. We're looking for a visionary teamplayer who thrives on long-term planning and constantly strives to improve our Quality Management System, both internally and externally. Your focus will be on active pharmaceutical ingredients (API).


Your QA Responsibilities:

  • Dive into the world of GMP and GDP regulatory requirements, crafting, reviewing, and maintaining SOPs that are fully compliant.
  • Take charge of organizing and supervising the execution of our QMS, ensuring seamless operations throughout the department.
  • Coordinate and manage the assessment and evaluation of our suppliers, manufacturing partners, warehouses, QC laboratories, distributors, transportation companies, and other service providers to guarantee their compliance with the highest quality standards.
  • Conduct audits of suppliers/contract manufacturers and warehouses, leaving no stone unturned in verifying their adherence to GMP/GDP standards.
  • Prepare and assist with authority inspections and customer audits of manufacturers, ensuring our partners maintain the highest level of compliance.
  • Collaborate with cross-functional teams to develop and execute quality agreements with customers and suppliers.
  • Co-conduct/Conduct internal audits, meticulously manage official inspections by regulatory authorities, and oversee the effectiveness of any Corrective and Preventive Actions (CAPAs).
  • Continuously assess our QMS through the application of risk analysis, providing insights and recommendations for improvement.
  • Record and manage deviations, customer complaints, CAPAs, and change controls, ensuring timely resolution and compliance.
  • Leverage risk analysis to establish and manage the batch certification processes, including the preparation of product checklists.
  • Prepare annual product quality reviews to evaluate and enhance our quality systems.
  • Review and recommend approval for data generated from manufacturers and laboratories to support the release of products by the Qualified Person.
  • Oversee exchanges with regulatory authorities, ensuring effective communication and compliance.
  • Ensure the proper storage of pharmaceutical products in accordance with regulatory requirements.
  • Share your expertise by training colleagues on SOPs, GMP, GDP, and other quality-related matters.


API Regulatory Affairs aspects:

  • Preparation, review and submission of high-quality DMF and cCEP applications for Active Pharmaceutical Ingredients for submission to European regulatory authorities
  • To review change control and submission of post approval changes to respective Drug Master Files
  • Effective communication with customers to ensure successful product registration by providing open part DMF, technical package and other query responses
  • Assistance to the technical teams in interpreting regulatory status of CAPAs.
  • Ensuring compliance with regulations set by EU authorities (EDQM, EMA)
  • Outlining requirements for labeling, storage and packaging
  • Using a variety of specialist computer applications (eCTD software/Extedo)
  • Liaising with regulatory authorities
  • Providing advice about regulations to manufacturers
  • Creation of product information data sheets and labels
  • Creation and update of the Flavine product specifications in line with regulatory and pharmacopoeias requirements
  • Submission of Regulatory reports like Amendments, annual updates
  • Responsible for updating the CEPs and LoA database
  • Review and recommend approval for data generated from manufacturers and laboratories within the function to support release of products by the Qualified Person as per §72a AMG
  • Preparation of annual product quality review
  • Active support to QMS in the management of complaints, deviation, CAPAs, change control
  • Active participation with QA and the Qualified Person in the definition, update, and life cycle management of the batch certification processes through a risk analysis-based approach, including the preparation of products check lists


Your Profile:

  • Degree: We prefer candidates with a background in Chemistry, Medicinal Chemistry, Pharmaceutical Chemistry, Biology, or Pharmacy.
  • Experience: You should have at least 2 years of experience in Quality Assurance, with a solid understanding of API, pre-formulation, and pharmaceutical technology. Proficiency in cGMP, GDP, ICH, QA systems, internal compliance, and drafting SOP documents is essential. Additionally, expertise in API QA releases and a strong grasp of key business processes within the supply chain and product lifecycle will set you apart.
  • Audits: Your ability to perform and compile audits of manufacturing sites, especially API facilities, is highly valued. If you're a certified auditor, even better
  • RA Experience: Exposure to API DMF/CEP submissions will strongly support your success in this role.
  • Languages: English and German
  • Travel: You should be open to traveling within Europe and abroad to visit our manufacturing partners, particularly in Asia.

If you're ready to take on this exciting challenge, we can't wait to hear from you Send us your application at hr@flavine.eu.

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