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Quality Assurance Manager or Assistant Quality Assurance (m/f/d) | Hannover | Pharma

Do you have experience in health information management and quality assurance?
If you would like to further your career in a consulting environment within the pharmaceutical industry,
then you have come to the right place!

Serum Life Science Europe GmbH is a development consulting firm for the biopharmaceutical industry. The
main shareholder is Serum Institute of India Pvt. Ltd., the world’s largest vaccine manufacturer. Originally
founded to promote vaccine research in Germany, SLS Europe now offers consulting and services for the
entire product development value chain for all kinds of medications.

We live product development – transforming ground-breaking ideas into life-saving medication.

To support our Quality Assurance Team we are looking for a

QUALITY ASSURANCE MANAGER

or

ASSISTANT QUALITY ASSURANCE

to join our team at the earliest opportunity (full time or part time employment possible).

Job Profile

  • Conduct QA review of GxP specific documents
  • Provide help, advice and guidance to operational departments on matters of quality
  • Coordinate, conduct and track training of new and existing staff
  • Create, maintain and revise departmental Quality Documents (SOPs, templates etc.)
  • Manage Quality Documents according to the respective written procedures
  • (Assist to) Planning, preparation and conduct audits (vendors, processes, systems, documents etc.)
  • (Assist to) Writing of audit reports and communicating findings and recommendations and
    evaluating the adequacy and completeness of corrective and preventive action plans
  • Provide support/participate in authority inspections
  • (Assist to) Ensuring the timely and effective follow up of all identified or assigned quality issues
  • Maintain required knowledge of applicable regulations, guidelines, company standards, procedures
  • Be part of national and international teams

Requirements

  • Master’s or bachelor’s degree in health information management, life sciences or comparable
    qualification
  • Prior Quality Management System experience
  • Knowledge of current GxP regulations and best practices
  • Preferably Issue Management and CAPA experience
  • Excellent written/oral communication skills in English and German and interpersonal skills
  • Knowledge in Microsoft Office applications, Adobe
  • Experienced in working with document management systems
  • Attention to detail with an ability to detect and correct errors in various types of documents
  • Self-starter and team-player
  • Well organized way of working

What we offer

  • Contribute to our mission to provide life-saving and affordable medication globally
  • Manage cutting-edge and challenging national and international projects in pharmaceutical
    development of vaccines, biologicals and other medicinal products
  • Participate in a diverse, international, experienced and highly motivated team that values common
    goals and supportive working environment
  • Benefit from our extensive on-boarding process with targeted training and support through
    personal mentoring
  • Develop yourself and your career within the company with external and internal trainings

Contact

Serum Life Science Europe GmbH
Dr. Christiane Meller, DirQA
Dr. Steffi Hansen, DirQA
30659 Hannover
+49 (511) 1699080
application@sls-eu.com