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Open nowPosted 38 days ago

Senior Specialist Quality Assurance

job-room.ch91,426 open roles

Where
Aargau, Switzerland
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Your applicationOpen nowSenior Specialist Quality Assurancejob-room.ch · Aargau, Switzerland

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The clock on this job

Early applications get read.

8.2% of postings close within 7 days. Measured by our own scanner across the market. job-room.ch postings stay open a median of 4 days.

Share of postings closed within
  1. 1.8%1 day
  2. 3.8%3 days
  3. 8.2%7 days
  4. 15.2%14 days
  5. 34.2%30 days
This job: posted 38 days ago

job-room.ch median: 4 days open

The posting

  • Life Sciences - Quality Management
  • Aargau
  • Contracting
  • Teilzeit, 60%
  • Immediately - the contract will last 6 months
  • Quality Assurance, Quality Control, GMP

Location: Stein

Contract duration: 6 months

Workload: 60%

Responsibilities:

  • Collaborate closely with cross-functional teams to work on growth projects as per site quality objectives and strategic goals. Ensure that project timelines and deliverables under the responsibility of QA/QC are fulfilled.
  • Provides guidance and quality oversight for QC.
  • Support growth projects and act as primary point of contact in QA for implementation of gLIMS (laboratory execution system).
  • Represents the QA support and guidance to the Quality Control (QC) department and ensures that GMP requirements are met and SOPs are followed.
  • Review and Approval of GMP relevant documents from quality control, including SOPs with focus on implementation of gLIMS.
  • Supervise and execute GMP compliance activities like changes (CRs), document management, non-conformities (DRs).
  • Write or revise SOPs in the area of expertise and be the owner of these documents.
  • Support QA for QC raw data review, as deemed required.
  • Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory GMP guidelines, health authority guidance, SOPs, HSE, etc.)
  • Management and reporting of KPIs.
  • Perform/support inspections and audits as required.

 

Requirements:

  • 7+ experience in projects in implementation of laboratory execution systems, within a quality-focused environment.
  • Strong background in cGMP regulations, including US, European and Japanese Pharmacopoeia.
  • Very good knowledge in laboratories/laboratory equipment/software qualification/validation.
  • Experience in interaction with health authorities (FDA, Swissmedic, etc.).
  • Project management certification would be considered as advantage (Green/Black Belt etc.).

 

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