Local Quality Specialist

Jobdescription

Location : Bulle,

Switzerland

Activity rate : 100%

Type of contract : Temporary

contract

Start date : ASAP

End

date : 31.12.2026

We are

looking for an experienced Quality professional to support our

local QA activities and ensure strong operational oversight. In

these roles, you will review and approve validation

documentation?such as risk assessments, protocols, and

studies?while contributing to daily QA operations and continuous

improvement.

Your key

responsibilities : Review and approve

validation documentation (risk assessments, protocols, studies, CPV

reports, project-related

deliverables).

Maintain oversight of

product-related documentation and ensure alignment with quality and

regulatory expectations.

Approve deviations,

investigations, incidents, and CAPAs, ensuring timely and effective

follow-up.

Support batch record review and

batch release / reject activities when

needed.

Provide day-to-day QA support to

manufacturing and supply operations in compliance with GxP

standards.

Collaborate with local and global

teams to embed and reinforce quality

standards.

Contribute to developing and

maintaining a strong on-site quality culture through guidance and

proactive engagement.

Lead or support the Site

Change Control Committee to ensure consistent and well-prioritized

management of changes.

Coordinate QA activities

related to change control and maintain communication with internal

and external stakeholders, including

CMOs.

Identify regulatory assessment needs

associated with proposed changes.

Support

quality strategies for assigned projects and contribute to process

simplification and continuous improvement

initiatives.

Qualifikationen

What will make you

successful : Master's degree in

Quality, Pharmaceutical Sciences, Biotechnologies, or related

field.

At least 5 years of QA experience in a

GMP manufacturing environment.

Strong

background in QA operations, including review of batch records,

validation protocols, and risk

assessments.

• Experience in biotech preferred;

pharmaceutical experience also

suitable.

Ability to work independently, manage

multiple priorities, and coordinate complex

activities.

Excellent communication skills in

French and English, with strong presentation and

stakeholder-management abilities.

High level of

professionalism, discretion, and

confidentiality.