Flex Team Member in Lab Support and Compliance - Zurich, Schweiz - ITech Consult

ITech Consult
ITech Consult
Geprüftes Unternehmen
Zurich, Schweiz

vor 1 Monat

Lena Schneider

Geschrieben von:

Lena Schneider

beBee Recruiter
Beschreibung

Flex Team Member (m/w/d) in Lab Support and Compliance

Flex Team Member (m/w/d) in Lab Support and Compliance / Sample Coordination -
Datenbanken
/ GMP /
Deutsch / HPLC / Gaschromatographie*
Project:For our customer, a large pharmaceutical company based in Basel, we are looking for a
Flex Team Member (M/F/d) in Lab Support and Compliance / Sample Coordination

Background:


The "Lab Support" group within the Lab Support and Compliance section belongs to the "Operations Support & Compliance" (OSC) department within "Synthetic Molecules Technical Development" (PTDC) at the Basel location.

The department is responsible for the "late stage" technical development of our synthetic molecules pipeline of drug substances (DS) and drug products (DP) for clinical studies.

The Lab Support & Compliance section is, among other things, responsible for the smooth coordination and qualification of laboratory equipment and offers efficient support to the analytical laboratories, thanks to proactive needs fulfillment and continuous improvement initiatives.


Main tasks and areas of responsibility:


  • Coordination/participation in the implementation of qualifications of assigned analytical devices (HPLC, GC,...), support of the analytical laboratories during device moves
  • Ensuring uniform and optimal planning, implementation and documentation of
device monitoring activities
Participation in all activities to ensure current GMP documentation

  • Maintenance of IT systems and databases in the GMP area, especially the device database (BM RAM).
  • Participation in maintaining device lists in connection with maintenance contracts.
  • Creation of taskrelated documents (e.g. SOPs) and responsible for their compliance
  • Analysis of the effectiveness of existing elements of quality systems including associated business processes and further development of a sustainable and quantifiable quality system as well as process improvements.
  • Representation and support of the other Flex team members of the section
  • Support with inspections and audits that affect the area covered
  • Continuous improvement, optimization and harmonization of established processes
  • Support/collaboration in taskrelated and relevant projects (GMP, IT and CSV, KAIZEN )
  • Supporting colleagues in the area of stability and samples management

Must Haves:


  • Laboratory technician training or natural scientist with university/technical college degree with experience especially in HPLC and GC
  • Min. 2 years of professional experience with a very good understanding of the workrelated regulations (GMP, ICH) and SOPs
  • Work accuracy and independence
  • Good IT knowledge and familiarity with databases (e.g. BM RAM)
  • Flexibility as well as organizational talent, high level of commitment and reliability
  • Good GMP and data Integrity understanding, high quality and safety awareness
  • Teamwork and communication skills
  • Good written and spoken German and English skills
  • Very high customer orientation, building and maintaining relationships with partners (within Roche and with external service technicians)

Nice to haves:


  • LIMS knowledge
  • Experience in the pharmaceutical sector e.g. in analytics/QC or quality assurance

Reference No
:

923322TP

Role:

Flex Team Member (M/F/d) in Lab Support and Compliance / Sample Coordination

Industry:

Pharma

Place of work:

Basel / Kaiseraugst


Workload: 100%

Start:


ASAP

Duration:
unlimited

Job Type:
100%


Salary:

CHF70' CHF176'010.69 per year


Schedule:

  • 8 Hour Shift
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