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Quality Management

vor 3 Monaten

Lengnau, Schweiz Gi Group SA Vollzeit

For our client we are looking for a

 

Quality Management / QM Qualification & Validation (m/f/d) 100%

 

Tasks & Responsibilities:

  • The role is involved in all GMP aspects of the execution of commissioning and qualification activities of computerized systems, working closely with the Execution Systems and the CSV Validation group to deliver state of the art computerized systems ready for commercial production.
  • The role is responsible for ensuring that qualification activities are executed in a manner that is compliant with cGMP regulatory expectations as well as to GAMP 5.
  • The role oversees/approves as Quality representative CSV activities of Fisher Clinical Services GmbH, Lengnau.
  • The role has active involvement in continuously improving quality standards for assigned quality systems and relevant production areas.
  • The role supports and encourages active knowledge management within the assigned department and drive continuous improvement processes
  • Apply the CSV/Data Integrity framework at the Lengnau site in compliance with cGMP.
  • Maintain and support of quality processes in the area of CSV as change management, defect management, document management.
  • Author, review and approve CSV project and lifecycle documentation according to RACI as QA role.
  • Ensures as QA representative the Quality compliance of all elements (e.g. URS, QRA) leading to commissioning and qualification activities (DQ, IQ, OQ and PQ) .
  • Review and approves CSV system specific documentation according to internal standards.
  • Assess and reviews Punches, Project Deviations occurred on assigned Systems during C&Q Phase.
  • Establish Guidance Documents (SOPs, WIs etc) based on request governing Commissioning and Qualification under the supervision of the direct Manager within the reporting Line.
  • Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management.
  • Acitvely contributes to quality improvement initiatives and deviation reporting and follow-up.
  • Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
  • Actively contributes to safety initiatives and issues as well as near miss reporting and follow-up.
  • Maintains commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
  • Takes personal accountability for his/her presence, performance, and productivity for the achievements of defined objectives.
  • Thinks and acts with a customer-centric mindset.
  • Is intellectually curious and embraces Practical Process Improvement (PPI).

 

Must Haves:

  • Degree (Bachelor or Masters) in Information Technology, Engineering or Life Sciences (Biology, Chemistry, etc.), Dipl. lng. or M.Sc. or B.Sc. or equivalent.
  • Strong operational experience preferably gained within the CSV/Data Integrity environment ideally on a Life Sciences / Pharma / Biotech Upstream/Downstream manufacturing faciIity
  • Several years of successful CSV experience on mid-sized and major projects with high complexity in the chemical, biotech-or pharmaceutical industry
  • Proven experience in cGMP, GLP & cGxP and especially Annex 11, 21 CFR Part 11 and CSV/Data Integrity on computerized systems
  • Excellent knowledge of GAMP 5 and corresponding regulations and guidelines (Europe and USA)
  • Knowledge of computerized systems` validation practices
  • Languages: German and English fluent in writing and spoken preferred
  • Able to work collaboratively with others to ensure successful outcomes.
  • Excellent verbal and written communication skills with the ability to present to a range of audiences at all levels within the organization.
  • Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks.

 

General Information:

  • Start date: ASAP
  • End date: 30.09.2024
  • Work location: Lengnau, Bern
  • Workload: 100%

 

Your Application:

Please apply online. For further information about the position, please contact your Kelly recruiter, Fatbardha Igrishta (fatbardha.igrishta[a]gigroup.com).



Branche: Chemieindustrie

Funktion: Produktion

Führungsperson: Nein

Anstellungsart: Befristeter Vertrag

Karrierestufe: Angestellte/r