Senior Quality Systems Specialist - CSV

Publiceringsdatum: 2024-12-20

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Jobbannons

Job Title: Senior Quality Systems Specialist- Validation and Computerized Systems

Location: Uppsala (possibility of hybrid work, min 3 days office)

Job Description :

Are you passionate about quality management in validation and IT systems? Galderma Uppsala is looking for a Senior Quality Systems Specialist with a deep understanding of validation of equipment and manufacturing processes and GxP-computerized systems. This is the perfect opportunity for you to make a significant impact.

Key Responsibilities:

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Maintain and improve the quality system for validation and qualification

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Support, train and coach the organisation and individuals in their work regarding validation and GxP-computerized systems

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Represent the department in projects as QA-IT.

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Participate in the maintenance organization as QA-IT of GxP-computerized system to secure that the system continuously remains in validated status.

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Participate, review and approve periodic reviews of GxP-computerized systems as QA-IT.

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Responsible as QA in change and non-conformities management cases related to GxP-computerized system in accordance with the company quality system.

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Monitor and implement regulatory requirements, standards and guidelines into the Galderma quality management system

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Contribute within the QA System group to the overall quality work

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Lead and drive the Quality processes and ensure that all the activities housed in the Uppsala site follow procedures, instructions, regulations, and legislations in the area. Review and approve documents in the quality system

Skills & Qualifications

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Advanced knowledge of GxP-computerized systems and their regulatory requirements (Annex 11 and GAMP).

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Advanced knowledge in EU GMP Annex 15, GHTF guideline, ISPE Baseline Guide Vol. 5 Commissioning & Qualification

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Knowledge of both GMP and ISO systems

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Knowledge and experienced in quality risk management principals

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Strong team player with the ability to plan and lead work

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Ability to make good ideas happen

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University degree in Pharma, Chemistry, Biology, Engineering or similar

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Professional proficiency in Swedish and English

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Preferably 8-12 years of experience in a similar role with working experience from medical device and/or pharmaceutical industries

What we offer in return

You join a team of 12 friendly, dedicated and experienced colleagues working with Galderma's quality management system, supplier control, internal and external inspection and as QA representatives in projects.

As Galderma's Global Center of Excellence for Aesthetics, we have in Uppsala a unique edge as we have the whole product chain from research and development to production on-site. Here, our nearly 600 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.

We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10-minute bike ride from Uppsala Central Station.

Next steps

We welcome your application via our company website CAREERS | Galderma. Apply as soon as the selection process is ongoing.

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If your profile is a match, we will invite you for a first virtual conversation with the recruiter.

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The next step is an interview with the hiring manager

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The final step is a panel conversation with the extended team

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.