Specialist Quality Systems GCP/GVP (m/f/d)

Good Clinical Practice (GCP) / Pharmacovigilance Practice (GVP)

Our client is well established in the pharmaceutical market as a medium-sized and family-run company. His business is developing and selling biofactor preparations worldwide with 1100 employees in more than 35 countries. The company’s product range is exclusively available in pharmacies and includes both prescription preparations as well as over the counter (OTC) products and food supplements.

 

Therapeutic areas focus on diabetic comorbidities, diseases of the nervous system, of the musculoskeletal system, as well as on stabilizing the immune system. Strong product development, a well-filled pipeline, excellent growth in sales and a significant increase in revenue, as well as smart investments - have made our client a very successful pharmaceutical company.

 

On behalf of our client, we are looking for a:

Specialist Quality Systems GCP/GVP (m/f/d)

Good Clinical Practice (GCP) / Pharmacovigilance Practice (GVP)

  • Bereich:

    Medical

  • Berufssparte:

    Qualitätswesen/Qualitätsmanagement

  • Arbeitsregion:

    Großraum Stuttgart

  • Art der Anstellung:

    Permanent

  • Kennziffer:

    26767

  • Aktualisierung:

    29.07.2021

Did we spark your interest? Then apply right here online or by e-mail, stating your earliest possible starting date and your desired salary.


Your tasks

As a quality all-rounder for our client, you will work in the most important specialist areas such as Global Clinical Research (GCR), Global Pharmacovigilance (GPV) and Quality Systems and will be the first audit contact. 

 

 

  • Conduct internal and external audits as part of the risk based audit program for the GCR and GPV team.
  • Provide GxP compliant advice and guidance to the GCR and GPV teams.
  • Contribute to clinical trial risk assessments and derive appropriate actions
  • Support the development, improvement and training of GxP-relevant processes and specification documents for the GCR and GPV team
  • Be responsible for the coordination of deviations as well as planning, tracking and effectiveness control of corrective and preventive actions (CAPA) for the GCR and GPV team.
  • Contribute to the creation of global and local process descriptions (including global and national SOPs as well as work instructions)

Your qualifications / Who you are:

  • You have a degree in natural sciences or comparable training
  • You have several years of professional experience in the areas of GCP or GVP in the pharmaceutical industry, preferably with an additional qualification as an auditor
  • You appreciate independent, structured, and precise work and are an assertive team player
  • You are characterized by analytical thinking as well as very good organizational and communication skills.
  • You have strong user skills in MS Office and other relevant pharmaceutical IT systems (DocuBridge, Amplexor, Trackwise, etc.)
  • You have a high capacity to travel
  • You act confidently and communicate professionally at all levels of cooperation
  • You are business proficient in English

 

You will be offered:

  • A dynamic, international environment with the opportunity to take on responsibility quickly and extensively, to contribute experience and knowledge and to implement ideas
  • a challenging job with a high degree of personal freedom
  • an attractive salary package
  • Varied challenges and exciting projects with a strong team spirit
  • Remuneration in line with the market and performance as well as additional benefits that you can use flexibly according to your needs, e.g. 
  • Allowance for direct insuranc
  • Compensation options for individual use as days off, retirement provision or payout
  • Bonago vouchers for special occasions
  • Supporting offers for your general well-being or for the compatibility of family and career
  • Health-promoting measures such as discounted conditions on over-the-counter (OTC) pharmacy items or internal health days
  • Flexible trust-based working hours and the possibility of mobile working
  • Central company headquarters with good local transport connections as well as mobility allowances
  • A wide range of opportunities for personal and professional development
  • Regular employee events

Ihre Ansprechpartnerin

Beate Aschoff
Senior Personalberaterin

Anschrift

Optares Medical GmbH & Co. KG
Beate Aschoff
Heiligengeist Höfe 8
26121 Oldenburg