For our Life Science client in Switzerland, we are urgently seeking a Quality Project Specialist.
Job title: Quality Project Specialist
Start date: ASAP
End date: 30/06/2017
Location: Basel, Switzerland
Languages: Fluent in German and English
- Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with GMP in TRD
- Reviews/Approves GMP relevant documents (eg work orders, packaging master documents, clinical study labels, batch records for packed material for both packed material from internal or contractors, Notifications of Extension to be issued due to revised expiry dates, analytical documentation for post-packaging-analysis)
- Perform review of GMP relevant documents for compliance with SOPs across several customer groups
- Clarify simple deficiencies in GMP documents with the line unit experts in own responsibility.
- Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up
- Provide support for quality relevant electronic systems
- Write and complete GMP relevant documents in own area of responsibility (eg CoAs, CoCs, BRR sheets, test scripts, SOPs)
- File and archive documents owned by QA (eg audit reports, CoAs, CoCs, BRR sheets etc)
- Support the line function in the use of GMP relevant IT tools and processes.
- Contribute to the evaluation of new tools
Minimum: Basic degree in laboratory, manufacturing or relevant discipline (apprenticeship or equivalent)
Desirable: Basic degree in science of relevant discipline (B.A., B.Sc. or equivalent)
- At least 2 years of relevant experience in a corre- sponding line unit function (eg laboratory, manufacture, packaging, IT, documentation)
- Communication skills to sufficiently address GMP and logistic related questions with the line unit experts, in order to maintain GMP records in a compliant status.
- Scientific, technical and regulatory knowledge in a specific area.
- Detailed knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
- Basic knowledge of drug development.
- Ability to analyze and evaluate GMP compliance.
We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive Hourly rate available for the contract; alternative market rates are also welcome.
We hope that the role will be of interest to you and understand that further information may be required prior to an application to the end client, please feel free to email or call me at anytime with any questions you may have.
Thank you for your time and we hope to hear from you soon.
Pharmaceutical & Life Sciences Business Developer
Recruiting Team MBA,
Michael Bailey Associates
Michael Bailey International is acting as an Employment Business in relation to this vacancy.