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Chemist, Pharmacist, Biotechnologist as Quality Assurance Coordinator - Quality Systems and Medical Software (m/f)

Bayer is a global enterprise with core competencies in the fields of health care,
agriculture and high-tech polymer materials. As an innovation company, it sets trends
in research-intensive areas. Bayer’s products and services are designed to benefit
people and improve their quality of life. At Bayer you have the opportunity to be part of
a culture where we value the passion of our employees to innovate and give them the
power to change.

Senior Quality Assurance
Coordinator for Quality Systems and
Medical Software (m/f)

YOUR TASKS AND RESPONSIBILITIES

  • Support management by providing oversight of quality systems as well as medical device
    software and applications
  • Responsible for the implementation of new electronic systems and quality processes to
    ensure an effective change management of existing software
  • Monitor local change management, quality relevant IT systems and training of quality staff
    in order to support adherence to global quality requirements
  • Assure compliance with respect to medical device software requirements by overseeing
    quality systems as well as change control and vendor management
  • Active participation in cross-functional teams to scientifically evaluate issues in order to
    mitigate business and compliance risk and to support release of safe products
  • Maintain awareness of Good Manufacturing Practice (GMP) trends and manufacturing
    processes and provide input to global procedures and directives to support continuous
    improvement within the quality unit

WHO YOU ARE

  • University degree in chemistry, pharmacy, biotechnology or an equivalent education
  • Several years of relevant experience within the GMP regulated pharmaceutical industry
  • User experience with medical software and medical devices; additional IT experience
    preferred
  • Good knowledge of international regulatory compliance (e. g. EMEA and FDA) and cGMP
    compliance
  • Demonstrated competence to make tough decisions under pressure to achieve corporate,
    site and departmental objectives
  • Ability to embrace changes in complex organizational structures
  • Passion for challenges and management of multiple, complex issues
  • Good interpersonal skills along with a cooperative attitude to team work
  • Shown communication and presentation skills with proficiency in spoken and written English

YOUR APPLICATION

We offer a competitive salary in an international environment as well as excellent
opportunities for professional and personal development. If your background and personal
experience fits this profile, please send us your complete application at www.career.bayer.de, submitting a cover letter, your CV and references as well as your salary expectation.
Country
Germany
Location
Berlin
Division
Bayer HealthCare
Contact us
Phone +49 214 30 99779
www.karriere.bayer.de
Reference Code
0000112124
Bayer welcomes applications from all
individuals, regardless of racial or
ethnic origin, skin color, nationality,
religion, philosophy, gender, age,
disability, appearance or sexual
identity. We are committed to treating
all applicants fairly and avoiding
discrimination.
Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector und geben Sie die folgende Referenznummer an: 0000112124