Quality Consultant (mfd)

This is where your work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

We are currently searching for a Quality Consultant (m / f / d) supporting Baxters external contract manufacturers Pharma (m / f / d) based in Bielefeld.

About this position :

Exciting role in our pharma quality team located in Bielefeld Germany that will support the quality governance of Baxter third party external contract manufacturers (ECM). You will have responsibility of oversight of ECMs located Germany and will also support other ECMs within Baxters global footprint.

Essential Duties and Responsibilities :

Act as Quality contact for assigned External Contract Manufacturer (ECM) partnerships.

Work with new ECM partners to ensure they meet Baxter quality requirements.

Assist with the negotiation development and maintenance of Quality Agreements between ECM and Baxter.

Work with Design Quality to execute technical transfer activities to ECMs. Support Quality Lead on new product development and tech transfers for pharma segment.

Manage Quality and Compliance related issues between ECM and Baxter.

May participate in Health Authority inspections and Baxter audits of ECM to ensure successful inspection outcomes and maintain a constant state of inspection readiness at ECM sites.

Perform quality risk assessments; develop mitigation actions and follow-up on CAPA implementation and monitor quality / process improvement initiatives at the ECM.

Define applicable metrics for new ECMs. Monitor and report quality performance metrics for established ECMs.

Ensure timely change implementation deviation / investigation review complaint investigations and CAPA closures at the ECM. Review and approve Annual Product Quality Review (APQR) reports for Baxter products manufactured at ECMs

Escalate and manage ECM issues within the Baxter Field Action process

Work with Baxter employees across multiple global sites and functions to assess the impact of an ECM Supplier Notice of Change (SNC).

Perform Baxter batch release for product at ECM sites.

Set and monitor quality system requirements to suppliers within the Finished Good and Contract Manufacturing space.

Execute SCAR and management ensuring effective and timely closure.

Drive improvements for ECM processes.

Qualifications :

Strong analytical skills and a proven track record in solving problems to support product quality impact assessments and lot disposition (release / reject) decisions.

Effective communicator internally and externally at all levels; excellent written oral and interpersonal communication and presentation skills (Proficiently in English and German is required).

Experience with medical product quality and compliance management systems.

Ability to make routine and some less routine decisions and drive for solutions independently.

Demonstrates flexibility and the ability to shift gears between projects comfortably.

Strong quality orientation required. Knowledge of pharmaceutical and / or combination product regulations e.g. FDA cGMP ICH pharmacopoeia Eudralex other global or regional equivalent

Experience in product lifecycle management (preferred)

Knowledge of Business Acumen; knowledgeable in current and possible future policies practices trends technology and information affecting his / her industry business and organization

Collaboration and Teamwork : Good communications facilitation coordination and team skills

Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision / instructions

Ability to manage the Quality relationship with assigned key suppliers / stakeholders

Willingness to travel (up to 10%)

Education and / or Experience :

BS in science or engineering. 7 years experience in Quality Manufacturing Engineering or related field.

Seven years of directly related experience. Pharmaceutical and / or combination product experience preferred.

Project management experience preferred

Manufacturing experience is desired in finished goods (drug and biologics) and contract manufacturing

Experience in root cause analysis corrective and preventive action methods; Expertise / experience in problem solving with quality tools such as : 6-sigma / 8-D / CAPA / FMEA / 5WHY etc.

Experience with Microsoft Office Trackwise Tableau and advanced statistical / process packages

What we offer you

As an internationally active company we offer you professional training opportunities and fair remuneration with above-average social benefits a company pension scheme a share plan for employees 30 days vacation plus special leave and additional insurance is a matter of course for us.

For further information please reach out to Sebastian Lange via E-Mail :

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion Baxter may decide to adjust suspend or discontinue as business needs change.

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability / handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.

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Required Experience :

Contract

Key Skills

Graphic Designing,Jboss Seam,Access Control,Consumer Durables,Application Programming,Client Services

Employment Type : Full-Time

Experience : years

Vacancy : 1