QA PL Drug Product

vor 2 Wochen


Visp, Schweiz Experis Switzerland Vollzeit

Experis is the global leader in professional resourcing and project-based workforce solutions.

On behalf of our Pharmaceutical company in Visp, we are looking for a QA PL Drug Product professional with experience in Drug Product Services.

General Information:

Duration: 8 Months

Location: Visp

Responsibilities:

  • Supervise Compliance & Customer quality agreement (QAA) activities for Drug Product Visp.
  • Establish and negotiate Quality Agreements (QAA) in close collaboration with Drug Product Services (DPS) in Basel / Stein and LONZA Drug Substance (DS) sites (e.g. Slough / Visp).
  • Act as point of contact for Drug Product QA related questions, topics, and complaints from customers related to the manufacturing operations. Support and manage interactions in cases of changes, deviations, technical complaints, out of specification results, and others.
  • Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
  • Act as QA representative in Project teams and represent QA in customer meetings during Technical Transfer.
  • Act as QA contact for specific projects and realize the interface for DR and CR with the customer (routine follow-ups).
  • Support and approve project / product specific risk assessments or regulatory specific risk or gap assessments.
  • Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
  • Work closely with QC-Project Leader (QC-PL) and MSAT for New-Product-Introductions (NPI).
  • Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions in line with current local SOPs.
  • Author, review and approve GMP-relevant documents and SOPs.
  • Support continuous improvement programs to establish an effective Quality Management System for Drug Product.
  • Support and approve project / product specific risk assessments.
  • Work experience: 5-10 years.

If this job interests you, please do send us your CV today through the link in the advert. However, should you have any questions, please contact Elaine Kanwar at +41 61 282 22 23.

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