QA Operations Specialist (m/f/o)

Peppercorn - talent acquisition. For more than 30 years, we support our clients in the personnel recruitment for fixed and temporary placements. We are a financially independent company within the FAVORIS group.

For an international pharmaceutical company located in Stein we are looking for a:

QA Operations Specialist (m/f/o)

Job Purpose:

Performs QA oversight of production and testing activities (shop-floor presence), ensuring compliance with cGxP, incl. Data Integrity and eCompliance, eg. as PU QA SPOC.  Acts as reviewer/approver of production (Assembly and Packaging) , records.  Provides specialist support in the evaluation and execution of investigations and changes.

Tasks & Responsibilities:

  • Review and approval of production, records (Assembly and Packaging)
  • Master Batch Record review and visual control of finished packed samples
  • Provide shop-floor QA support and oversight of production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
  • Performs routine documentation activities
  • Support exception investigations for non-critical deviations
  • Supports change control activities relating to non-complex changes
  • Support OpEx improvement projects

  • University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
  • Fluent in German and English
  • Strong knowledge of GMP
  • Several years of experience in pharmaceutical quality control, quality assurance or production
  • MS Office applications and other standard IT applications supporting Quality activities
  • Good collaboration skills
Nice to have:
  • Qualified Person
  • Experience in MES and SAP
  • Experience in Assembly and packaging
  • Experience in product release process or review processes

Start date: 01.05.2021
End date:  31.12.2021
Work location: Stein
Workload: 80-100%

We look forward to your application via our homepage

Peppercorn Human Experts AG
Auberg 2
4051 Basel

Anja Glinschert
Telefon: 058 255 31 01

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