Description
QA Compliance Manager wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- BSc in science or a relevant discipline. MSc will be of advantage
- Background in compliance management along with 5+ years of working experience in TRD, production or QA
- Profound knowledge of GMP, technical development, production and / QA
- Sound scientific, technical and regulatory knowledge
- Experience in analyzing and evaluating GMP compliance
- Languages: fluent English both written and spoken, German would be a big plus
Your tasks:
- Managing portfolio of projects, providing a discipline and /or supplying a service with a team of associates
- Evaluating and approving deliverables and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance
- Supervising project related activities including. development of new tools, processes, Quality Initiatives, etc.
- Writing, reviewing and approving documents plus providing, inspecting and auditing activities as well as assisting the team in evaluating of new QA tool
- Supporting TRD line functions in GMP compliance related issues in area of expertise as well as working on the improvement of internal and external guidelines regarding quality and safety
- Assisting the team in preparing PAI along with contributing to the internal compliance policy and regulations
- Managing deviations, investigations and CAPAs and providing reports for change requests, technical complaints of the products and processes
Start: - ASAP
Duration: 06MM++
Location: Basel, Switzerland
Ref.Nr.: BH9325