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QA/QC Specialist
View: 135
Update day: 01-04-2024
Location: Basel Basel-Stadt BS
Category: Quality Assurance / Quality Control
Industry: Staffing Recruiting
Position: Entry level
Job type: Full-time
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Job content
Do you want to work in a big pharmaceutical company? Do you have experience in QA for Biologic? You should then read the following lines!Our client, based in Basel, is looking for a QA / QC Specialist for a contract until the end of the year with possibility of extension.
Your Responsibilities
- Perform review of GMP relevant documents for compliance with SOPs across several customer groups (e.g. manufacturing or packaging master documents, batch records for material manufactured and/or packaged internally or at contractors, TEDI documents, SOPs, analytical raw data, analytical methods, analytical validation protocols and reports, etc.).
- Perform review and approval of GMP relevant documents derived from approved sources (e.g. analytical working sheet templates, GLIMS specifications).
- Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up. Propose and survey implementation of agreed preventive actions.
- Act as contact person for QA questions of quality relevant electronic systems (e.g. IMOS, GLIMS, TQW, QP database, TEDI, ESOPS, Pathlore), and/or as a contact person to the needs of the line unit (e.g. CoA needs from different customers; TEDI formats, etc.).
- Write and complete GMP relevant documents in their own area of responsibility (e.g CoAs, CoCs , BRR sheets, test scripts, SOPs with extended applicability).
- Perform statistical interpretation of trending data collected by QA (e.g. in TQW or audit database). Compile trending reports and suggest conclusions.
- Collaborate with other associates to support the service function of QA.
- Evaluate new QA tools (e.g. IT systems, processes)
- Participate in knowledge exchange within and outside of TRD.
- Participate in training and coaching of new and temporary employees in QA and from associated line functions.
- Lead and support direct reports in line with Novartis values and behavior including objectives setting, performance evaluations, development planning and participate in recruiting process.
- Minimum Education: Basic degree in laboratory, manufacturing or relevant discipline (e.g. apprenticeship, Bachelor or equivalent; Associates of Arts degree)
- Desirable Education: Basic degree in scientific or relevant discipline (advanced technical college, BA/BS or equivalent)
- Experience with biologic process
- Sound scientific, technical and regulatory knowledge in a specific area.
- Detailed knowledge of relevant GMPs, working knowledge of safety and environmental regulations and guidelines.
Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
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Deadline: 16-05-2024
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