Technical QA Manager

vor 15 Stunden


Basel, Schweiz Talentify Vollzeit

Description

Our client is seeking an experienced Technical QA Manager to join their IMP Quality Operations Unit in Basel. This team plays a critical role in ensuring GMP compliance and quality oversight for Investigational Medicinal Products (IMPs) manufactured and packed in Switzerland. The ideal candidate will bring extensive expertise in qualification and validation for synthetic molecule manufacturing and quality control, combined with a strong background in pharmaceutical quality assurance and GMP standards.

Key Responsibilities:

  • Oversee and ensure QA supervision of qualification and validation activities for GMP-relevant equipment in synthetic molecule production and/or quality control.
  • Establish guardrails for operational facilities, ensuring adherence to GMP and quality standards.
  • Provide technical expertise for reviewing and approving quality-related documents, such as qualification plans, risk analyses, change management, deviations, CAPAs, and SOPs.
  • Perform deep root cause analyses to investigate and resolve complex issues, acting as a facilitator or subject matter expert.
  • Drive optimization initiatives within IMP Quality Operations, supporting stakeholders to achieve IMP goals and continuous improvements.
  • Represent the area of responsibility during health authority inspections and internal audits.
  • Support end-to-end cGMP activities to maintain compliance and ensure the quality of IMP products in alignment with health authority and company standards.

Requirements:

  • Academic degree in Engineering, Chemistry, Life Science, Pharmacy, or equivalent.
  • 10+ years of experience in the pharmaceutical industry, with at least 5 years in quality assurance.
  • Extensive experience in qualification/validation for synthetic molecule manufacturing and/or quality control.
  • Strong knowledge of current data integrity (DI) requirements and global GMP standards.
  • Fluent in German and English, both written and spoken, with excellent communication skills.
  • Proven track record in health authority inspections and internal GMP audits.
  • Team-oriented mindset, high self-motivation, and the ability to influence effectively across all organizational levels.

If you are interested please apply directly, or send me your CV at cpflieger@actalentservices.com.

Job Title: Technical QA Manager

Location: Basel, Switzerland

Job Type: Contract

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