QA Associate
Job Description
ROLE OVERVIEW
Inside the Quality Assurance and Compliance team we are looking for someone passionate to support quality and manufacturing organization. Ideal candidate will be in charge of documentation activities, training and QMS maintenance ( deviations, change controls). Moreover he/she will be Quality Assurance representative to bring compliance and quality mindset in GMP workshop and research and development area dedicated to the manufacturing of BDS clinical trial products.
RESPONSIBILITIES:
From a QA document control perspective
- Perform QA document control activities, including ( issuance of documents, revision, activation Training update…) in compliance with GMP practice
- manage the flow, review, approval , issuance Archiving of GXP related technical documents
- backup as Superuser routine work on eDMS, eQMS, eLMS, PleaseReview
- Manage common quality mailboxes (QA, DCQA, etc…)
From a Manufacturing perspective
- Manage supplier notification for raw materials and assemblies.
- Perform raw material and assemblies release for BDS manufacturing based on Quality agreement, specification and incoming goods controls.
- Manage deviations for raw materials and supplier complaints as needed
- Review and approval of document, standard operating procedures, technical document (URS, drawings, pest control report ... ) related to raw materials and suppliers
- Provide support for inspection by authorities as well as internal and external audits.
- Contribute to the optimization of quality processes based on GMP.
- Perform other relevant duties as required.
EDUCATION AND DESIRED EXPERIENCE:
- BSc, or equivalent biochemical engineering, biochemistry, biology, pharmacy or related discipline
- At least 2 years of experience in an industrial setting under GMP standards or equivalent
- Experience in biotechnology (quality management of USP/DSP) desirable.
- sound knowledge of current Swissmedic, EMEA, FDA regulation and ICH guidelines
- Strong sense of discipline, good organization skills, excellent team orientation and hands-on approach to work
- Fluent English both written and verbal; proficiency in French is highly desirable
- Autonomous, reactive and flexible to changing priorities
LOCATION:
You will join us, in a picturesque city of La Chaux-de-Fonds, Neuchâtel, Switzerland.
This is a rare opportunity to join our growing scientific team at the very start of something special. You will become a part of the foundation of a new company imprint…