For our client, a pharmaceutical company in Basel, we are looking for a
QA Associate
Resposibilities:
1. Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility
2. Write and review GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
3. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidances, SOPs etc.).
Individual specific tasks
• Manufacturing and analytical Batch Record Review for batches of the CHAD department (internal/external)
• Support paper archiving in TRD QA Ops NCE
Each associate is allowed to perform an assigned task only after completion of the related trainings.
Deputizes for:
1. Peers with same area of responsibility.
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. Maintain sound working relationship with internal customers and external part-ners.
3. Meet quality and timelines in area of responsibility.
4. Feedback from team members.
5. Act in accordance with our client's standards in particular; cGMP, ethical, health, safety and environment (HSE), and information security (ISEC).
Education
(minimum/desirable): Technician (5 years' experience)
Bachelor ( 3 years' experience)
Languages: Fluent in site language, English required (adequate knowledge oral & written).
Experience/Professional requirement:
Communication skills to sufficiently address GMP and logistic related questions with line unit experts. Scientific, technical and regulatory knowledge in a specific area.
Basic knowledge of drug development.
Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines. Good organizational skills.
Duration:6 monthsStart date:asapWorkload:100%
*Please note that the shortlisting for this position starts after three working days.
Please send your application including your CV and your job certificates and degree certificates in one pdf file to zahra.safari (at).kellyservices.ch.