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Title:  QA Compliance and Project Senior specialist

Requisition ID:  36072
Date:  Nov 26, 2021
Location: 

Le Nouvion, Aisne, FR

Department:  Quality
Description: 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $1.84B in 2019. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Essential Duties and Responsibilities:

 

Plant CAPEX and programs

- Represent quality department in major projects teams

- Ensure compliance of new equipment and programs with quality requirements

 

Continuous improvement

- Participate in improvement projects, particularly aiming to improve Cost of Poor Quality

- Analyze the risks.

o Support the strategy for risk management

o Build the basis for the control of operational processes, the preventive maintenance plan and the calibration plan through risk analyses of all operational processes.

o Contribute to risk control by participating in risk analyses and proposing actions.

 

Quality process management.

- Ensure that quality processes are defined, in place, capitalized and efficient, propose action plans to improve the performance of quality processes.

- Manage quality processes through KPI (Europe and LN).

- Internal audits:

o Define the annual internal audit schedule.

o Ensure a part of the audits according to the annual audit plan.

o Ensure the follow-up of internal audits carried out.

- Review and approve the Annual Products Reviews for Westar® products

- Be the local referent for DMF and manage Westar local files

- Ensure the compliance of data during creation/modification of articles (CCM and ROS)

- Review and approve the SOI and linked templates

- Manage the internal process to ensure the adequation of SOI with Enterprise documentation

 

Validations

- Monitor the proper execution of the validation program via the Site Validation Plan

- Participate, if necessary, in the validations described in the SVP (expertise on the method, participation in FMEAs, etc.).

- Review and approve validation files.

 

Support to lab

- Manage the GMP specialist, in charge of local data integrity program management

- Review and approve lab deviations

- review and approve lab Out of Specifications

 

Work in accordance with GMP rules

- Ensure scrupulous compliance with the rules and proper application of procedures, particularly with regard to personal hygiene, cleanliness, product handling and cross-contamination on mixed articles.

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $1.84B in 2019. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program

Apply now »