In this position as QA Project Specialist you will support the supervisor in the timely release of GMP relevant documents. Furthermore, you will support project deliverables and objectives according to agreed timelines and standards as well as adherence to compliance with GMP.
Write and complete GMP relevant documents in own area of responsibility (e.g. CoAs, CoCs , BRR sheets, test scripts, SOPs)
Review of GMP relevant documents for compliance with SOPs (e.g. 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.).
Clarify deficiencies in GMP documents with the line unit experts
Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up
File and archive documents owned by QA (e.g. audit reports, CoAs, CoCs, BRR sheets etc.)
Support quality relevant electronic systems (e.g. GLIMS, TQW, TEDI, ESOP)
Support the line function in the use of GMP relevant IT tools and processes
Contribute to the evaluation of new tools (e.g. IT systems, processes)
Participate in training of new and temporary employees
QA Project Specialist (m/f)
Degree in laboratory, manufacturing or science
Minimum 2 years of working experience in the pharmaceutical industry (e.g. laboratory, manufacturing, packaging, documentation)
Scientific, technical and regulatory knowledge
Good knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines
Basic knowledge of drug development
Ability to analyze and evaluate GMP compliance
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
Strong organizational skills.
Knowledge and flexibility to work with relevant IT systems
Used to work in an international, multi-cultural and cross-functional team
Fluent in German (spoken and written) and advanced English skills
Adecco Switzerland is the Swiss leading provider of HR solutions in the working life cycle area with more than 50 years of experience in this field. The company has a workforce of over 450 and is represented across Switzerland with a network of 100 branches in over 50 locations. Adecco Switzerland offers a diverse services portfolio: Temporary staffing and permanent placement, outsourcing, training and personal development, HR consulting as well as customer-oriented project services.
More than 2' 000 job offers available on www.adecco.ch
Frau Simone Dünneisen, Consultant Retail, looks forward to answer your questions by phone or eMail.
You can apply directly online, or by eMail. Please mention reference 152/SIDU/1002-235 in your application.