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Senior Quality Assurance Complaint/Deviation Coordinator Medical Software (m/f)

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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
Complaint/Deviation Coordinator
Medical Software (m/f)

YOUR TASKS AND RESPONSIBILITIES

  • Support management by providing oversight of customer complaints and emerging
    discrepancies associated with medical software and applications
  • Assure timely investigation and resolution of issues related to drug manufacturing
    and quality control
  • Active involvement within cross-functional teams to implement corrective and preventive
    measures based on scientific principles and root cause analysis taking all manufacturing
    processes, quality testing and customer requirements into account
  • Promote decisions to drive improvement of processes through own expertise and
    experience
  • Prepare Standard Operating Procedures and investigation documents to mitigate future
    business and compliance risk to maintain product supply of biopharmaceutical products
  • Provide expert opinion related to product safety matters under consideration of related
    production discrepancies as well as of related change control and quality testing data

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.career.bayer.de
Reference Code
0000112137
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: 0000112137