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Quality assurance specialist

Visp
Coopers Group GmbH
EUR 30’000 - EUR 80’000 pro Jahr
Inserat online seit: 14 Januar
Beschreibung

Talent Acquisition Consultant at Coopers Group AG - Life Science
Location: Visp

Responsibilities

Act as QA representative in Project teams and represent QA in meetings

Act as QA contact for specific topics and realize the interface for DRs and CRs

Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations

Support and approve 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.

Represent Drug Product QA topics during regulatory inspections.

Support continuous improvement programs to establish an effective Quality Management System for Visp DPS.

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.

Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.

Requirements

University degree or equivalent in Chemistry / Biology / Biotechnology or a related field

Long-term experience working in the GMP environment of the pharmaceutical industry

Experience working in a QA department Drug Product

Seniority Level
Associate

Employment Type
Contract

Job Function
Other

Industries
Pharmaceutical Manufacturing and Biotechnology Research

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