QA/QC Specialist, Contract, Switzerland
Start Date: 01/11/2016
End Date: 28/02/2017
Job description: TRD QA Quality Project Specialist (QPS)
Support the supervisor in the timely release of GMP relevant documents. 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. Major Activities (Describe main activities)
1. Perform review of GMP relevant documents for compliance with SOPs across several customer groups (eg manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at con-tractors, TEDI documents, SOPs, analytical raw data, qualification documents etc.).
2. Clarify simple deficiencies in GMP documents with the line unit experts in own responsibility.
3. Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up.
4. Provide support for quality relevant electronic systems (eg GLIMS, TQW, TEDI, ESOP)
5. Write and complete GMP relevant documents in own area of responsibility (eg CoAs, CoCs, BRR sheets, test scripts, SOPs).
6. File and archive documents owned by QA (eg audit reports, CoAs, CoCs, BRR sheets etc)
7. Act as a contact person to the needs of the line unit (eg CoA needs from different customers, such as eg CMC, Qualified Persons; distribution of TEDI documents to external customers, etc.).
8. Support the line function in the use of GMP relevant IT tools and processes.
9. Collaborate with other associates to support the service function of QA.
10. Contribute to the evaluation of new tools (eg IT systems, processes)
11. Participate in knowledge exchange in TRD.
12. Participate in training of new and temporary employees
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 the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.
Key Words: QA/QC Specialist, GMP, SOPs, electronic system, archive documents, TRD, laboratory, manifacturing, cGMPs, drug development, contract, English, pharmaceutical, Switzerland
Serena Edith Alpi
Michael Bailey Associates
Job code: 112210
Michael Bailey International is acting as an Employment Business in relation to this vacancy.