QA Associate

**ROLE OVERVIEW**

**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 Facililty validation perspective
- Support the review of validation master plan.
- Review equipment and computer qualification/validation for laboratory and GMP manufacturing area including CSV elements.
- Participate to the evaluation of documents, deviations, CAPA, changes, and internal audit findings in the scope of the QA Facility.
- Provide support for inspection by authorities as well as internal and external audits.
- Optimise facility quality processes based on EU/FDA GMP requirements and guidelines.
- Perform other relevant duties as required.

**EDUCATION AND DESIRED EXPERIENCE**:

- BSc, or equivalent biochemical engineering, biochemistry, biology, pharmacy or related discipline
- At least 3 years of experience in an industrial setting under GMP standards or equivalent
- Experience in biotechnology (quality management of USP/DSP).
- knowledge of current Swissmedic, EMEA, FDA regulation and ICH guidelines
- Demonstrated experience in qualification/validation review
- Knowledge of USP, EP and GAMP5 and, 21 CFR part 11. is a plus
- Strong sense of discipline, good organization skills, excellent team orientation and flexible to changing priorities
- Fluent English both written and verbal; proficiency in French is highly desirable

**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

Business Unit: Quality Unit (Compliance and facility)

Type of Contract: Permanent

Employment Rate: Full Time