Overview
QA Manager Jobs in Basel, Switzerland at Actalent
Title: QA Manager
Company: Actalent
Location: Basel, Switzerland
Our client is looking for a Senior QA Manager GMP/GDP to join its team in Basel.
Key Responsibilities:
Provide GMP/GDP quality assurance expertise during development and commercialization of the company’s products
Ensure all required quality activities are initiated and completed according to the development stage
Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards
For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed
Establish a quality risk management approach in projects based on six sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
Manage all required activities to support release of active ingredients, commercial products and/or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controls
Notify CMC team and management of potential quality, regulatory and lead time issues
Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
Write, review, and/or approve internal SOP’s and other GMP/GDP related documentation
Support review and optimization of the company’s pharmaceutical quality system by preparing review of relevant CMO’s Key Performance Indicators
Release of DS and DP Bulk as defined in the relevant release SOPs
Requirements:
University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum
5 years of experience in different positions like pharmaceutical product development/ quality control / analytical development / chemical production or similar operational positions in the pharmaceutical industry
5 years of experience in quality assurance of drug substance and/or drug product
Knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution
Good knowledge of (c)GMP/GDP’s
Fluent in English
Location: Allschwil, Switzerland
Duration: until 31/07/2026
Start date: 04/08/2025
If you are interested please apply directly, or send me your CV at [email protected].
