For our client, one of the leading international pharmaceutical companies headquartered in Basel (Switzerland), we are looking for a motivated personality in the function of a
QA / QC Specialist (m/f), Basel, 100%
- Initiation and supervision of qualification processes of complex analytical systems including the corresponding software qualification. Responsible for the high quality / data integrity of qualification processes, SME-in the related fields. Participator/leader of global harmonized continuous improvement projects. Writing and reviewing of relevant SOPs in compliance with given guidelines.
- Initiate, support and supervise qualifications of complex analytical equipment (including corresponding software qualification) in close collaboration with the analytical laboratories.
- Act as a trainer for relevant qualification topics.
- First point of contact to Quality Compliance in all topics related to your field of work.
- Actively participate in global teams, projects, networks and/or platforms. Fulfil all related tasks and responsibilities related to own discipline.
- Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s).
- Meet quality, quantity and timelines in all assigned projects, networks and/or platforms. Improve continuously quality 7 data integrity standards of laboratory equipment.
- Interact with authorities / inspectors where appropriate. Act as SME regarding system qualification topics.
- Manage deviations related to complex analytical systems.
- Technical expert studies with PhD and 0-2 years
and relevant experience; Master of Science with 4 years of relevant experience; Bachelor of Science or equivalent technical education with 8 years relevant experience in industry or equivalent
- Fluent in English (oral and written) Basic skills in local site-language (German), as
required for the position & Awareness of safety regulations and for safe
handling of chemicals and equipment.
- Appropriate number of years of experience in an analytical GMP environment.
- Very good knowledge of qualification processes for laboratory systems in a GMP environment including software qualification (CSV) and related technical tools and software.
- Scientific project management and leadership skills
- Good knowledge on relevant regulatory guidelines and good understanding of regulatory expectations
- Very good with laboratory and/or technical tools. Ability to work in and lead teams.
- Good knowledge of software and computer tools.
- Good documentation skills and Good presentation skills
- Very good communication skills
Place of work: Basel
End of assignment: December 2021
Please apply online. For further information about the position, please contact: Mrs Insa Voss (+41 61 270 80 07).
We are looking forward to getting to know you!