QA Expert (m/f/d)

QA Expert (M/F/D)

Tasks:

• The objective of this resource within the Quality Ops organization is to provide support as a Quality Assurance Senior Expert in the frame of implementation of a new Fill and Finishing and Visual Inspection area

• He/she could also be involve in routine GMP operations for Fill and Finishing area.

• He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.

• This resource will be specifically responsible for the following tasks:

• Prepare, evaluate, and approve controlled documentation creation/revision.

• Review of deviations in the framework of production events within quality systems (i.e. Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements.

• This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant CAPA.

• Attend all meetings relevant to perform the above-mentioned tasks.

• Respect the escalation process.

• Ensure completion of relevant training and software access management according to policies.

• Other tasks related to conventional quality oversight might be occasionally requested to support the team (e.g. continuous improvement initiatives, GMP tour in classified areas, batch review, etc.).

Qualification:

• Technical and scientific academic background (Master’s degree – Bac +5)

• 2–3 years of operational cGMP experience in a Quality Operations department within a pharmaceutical production site for sterile injectable products.

• Holistic knowledge of production processes (from cell culture to aseptic filling): unit operations, equipment, gowning, environmental controls, physicochemical and biological laboratory testing, etc.

• Knowledge of Quality guidelines (cGMP) and Quality Systems (Deviations, CAPA, Change Control, Training, Documentation, etc.)

• Strong writing skills for documents in French and/or English

• Languages: French and English

• Proficiency in PC usage and Microsoft Office suite

• Teamwork skills

• Agility and autonomy

• Work mode: Minimum of 4 days on-site

• Reporting to the QA Manager, with daily interactions with Manufacturing, Engineering, Sterility Assurance, Quality Operations, Training, etc.

Requirements: 

Start: asap

Duration: 31.05.2025 + possibility to extend

Capacity: 5 days per week

Location: Greater Neuchatel Area