For our client in Basel we are looking for a QA/QC Specialist for a 5 month contract.
Period: ASAP- 28.02.2017
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
Key Performance Indicators (Indicate how performance for this role will be measured)
1. In accordance with departmental objectives such as support of projects with agreed quality and delivery dates, passing of internal and external inspections.
2. Act in accordance with standards in particular; GMP, ethical, health safety and environment (HSE), and information security (ISEC) standards.
Ideal Background (State the preferred education and experience level)
Education (minimum/desirable): 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)
Languages: Fluent in site language, English required (adequate knowledge oral & written). Experience/Professional requirement:
1. At least 2 years of relevant experience in a corre- sponding line unit function (eg laboratory, manu- facture, packaging, IT, documentation)
2. 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.
3. Scientific, technical and regulatory knowledge in a specific area.
4. Detailed knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines.
5. Basic knowledge of drug development.
6. Good organizational skills.
7. Ability to analyze and evaluate GMP compliance. 8. Knowledge and flexibility to work with relevant IT systems.
For more information, please contact: