AKTUELLE VAKANZEN

Quality Assurance Manager (m/w/d)


Our customer is an independent international Pharma company with its own R&D activities. Head-quartered in Frankfurt, Germany, the family-owned firm with a 100 year-plus history is represented in more than 90 countries worldwide. Due to continous growth we are looking to fill the position of Quality Assurance Manager (m/w/d) site Dessau

Your Contribution

Manages the QA/QC team and activities at the assigned manufacturing site. Responsible to coordinate the implementation of the quality and regulatory relevant regulations, standards, guidelines and procedures including applicable documentation on site. Support the Quality organization to manage the Deviation handling, NCR-results, CAPA, change control and all other quality related activities applicable to the assigned site, including all QC activities performed at the local QC Laboratory. Responsible to guarantee the status « ready for inspection » on site.

Key Activities & Accountabilities

Reporting to the Senior Director Quality & Compliance of Global HA Fillers Manufacturing Centers, your main duties are to:

  • Manage QMS and relevant regulatory activities in accordance with applicable standards and regulation and guarantees the application of ISO13485, MDSAP & 21CFR part 820
  • Manage key Quality processes at the assigned site (NCMR, CAPA, Change Control, Documentation control, Production Batch record review...) as required by the applicable QMS
  • Manages local QC team at the assigned site
  • Identify potential or real non-conformities related to the products, processes and quality management system
  • Organize and ensure proper QA related training to assigned manufacturing site employees,
  • Interact with contractors to ensure continuous and proper services in QC, Metrology, In-coming goods control and release, maintenance, engineering...
  • Ensure relevant applicable services and QA agreements are constantly active and updated
  • Provide necessary documentation to constantly ensure on time release of batches from assigned site
  • Provide relevant QA support and guidance to manufacturing operations of assigned site for any QA related questions within manufacturing activities
  • Participate to the establishment and execution of internal audits program
  • Support the Senior Director Quality & Compliance during audits & inspections
  • Participate to risk management activities, to corporate meetings (QA meeting, work session, ...) and to continuous improvement by identifying innovative solution, tools, software to support day to day activities
  • Communicate regular report on QA performances to internal & Corporate management
  • Support the Swiss sites` Quality Assurance and Regulatory Affairs in providing information for Notified Body and Regulatory Authorities regarding applicable questions related to manufacturing and QMS applicable to the assigned site
  • Support the company`s Corporate Regulatory Affairs and North America entity to prepare, present and maintain dossiers to be submitted to Regulatory Authorities for Rest of World and US registrations
  • Act as back up for the Regulatory Affairs and Quality Assurance team when requested,
  • Seek to respect of using of resources allocated by the management to attain the objective on time
  • Supervise and Manage the Quality Assurance and Quality Control team at the assigned site
  • Define individual yearly objectives and organize yearly performance reviews of individual objectives defined for each QA team member

Qualifications & Experience

  • Master / Engineer’s degree in a biomedical / scientific / law field,
  • At least 5 years’ experience in Quality ideally in the pharmaceutical/medical devices industry (development, manufacturing)
  • Knowledge of European, American, Australian and Canadian standards, laws and guidelines applicable to medical devices
  • Strong knowledge of management of quality system (21 CFR part 820, ISO13485, MDSAP)
  • Knowledge of GMP environment
  • At ease with Microsoft Office and usual software tools
  • Fluent in German and English; French is a plus
  • Ability to balance the business/commercial objective with the detail required to define a compliant process
  • Accurate, clear and client communication of technical information, whether verbal, written or face to face
  • Organized approach and able to work to tight deadlines
  • Strong customer-oriented mindset to constantly think and act as solution provider
  • Strong proactive behavior
  • Excellent communicator with a solid capacity to convince through clear and accessible communication
  • Dependable and committed to deliver tangible results on time and with highest quality standard

 

Are you interested in this challenging position? Then please contact us and send your CV to:

Dr. Andrea Sandmöller

E-mail: as@search-notchdelta.com; Tel.: +49 - (0)172 - 3546586

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Interesse?
Jetzt kontaktieren

Dr. Andrea Sandmöller
Tel +49 611 962 5525

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