QA/QC Specialist

☞ Randstad Switzerland

View: 120

Update day: 25-03-2024

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.
Your Profile
  • 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.
Do not waste any minutes, apply now! We are looking forward to receiving your application.

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
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Deadline: 09-05-2024

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