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Qualification Project Manager (m/w/d)
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Basel, Schweiz |
Freelance
Job title: Freelance Qualification Project Manager (m/w/d)
Industry: BiotechSkills: Quality Control, Equipment Qualification, HPLC, Elisa
Start of project: Beginning of July
Duration of the project : 6 Months
Project volume: 1008 hours
Location: Basel, Switzerland
Tasks:
- Lead and establish analytical infrastructure services for biologics, small molecule and peptide commercial Drug Products in frame of project ramp-up for a new commercial Drug Product facility
- Liaise with internal partners and external network as well as external partners to ensure on-time delivery of project milestones
- Review and approve documentation (installation/qualification plans and reports) related to laboratory systems as required, following applicable SOPs and all current documentation practices
- Ensure compliance of laboratory systems according to cGMP and current best practices and regulatory guidelines
- Authoring of cGMP documents e.g. procedures (SOPs)
- Participate as Subject Matter Expert in audits and inspections
Qualifications:
- Academical degree or apprenticeship in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field
- Significant experience in pharmaceutical industries and cGMP controlled environment
- Broad know-how and understanding of current requirements / standards related to instrument qualification and corresponding documentation
- Experience in analytical methodologies like e.g. HPLC, ICief, UV-VIS, Elisa, CE-SDS etc.
- Experience in method transfers and method validation would be a plus
- Knowledge of lab quality systems like LIMS, Tiamo or Empower/Chromeleon
- Capability to work independently and in a dynamic & fast-pacing project environment
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
Anstellungsart:
Kontakt
Lars Uhl
13166
Biotech
03.07.2023
6 Months
Freelance
