Commissioning, Qualification & Data Manager
Q-Med AB / Maskiningenjörsjobb / Uppsala
2024-12-17
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hela Sverige Job Title: Commissioning, Qualification and Data Manager
Location: Uppsala, Sweden
Job description :
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You lead the team who strategize, plan, lead, create and execute deliverables as they relate to Verification and Qualification of assigned new and modified Facility, Utility and Manufacturing GxP systems (including Operational Technologies) throughout their lifecycle.
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You ensure that plans for requalification activities as they relate to the assigned applicable area of responsibility are executed.
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You manage the engineering data platforms associated with engineering master data.
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You play a key role in representing the qualification strategies and activities during Regulatory (GxP) Inspections.
Key responsibilities:
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Set direction for development of the Commissioning, Qualification & Data areas to improve solution setup and ensure way of working, processes and policies address current and future business and compliance needs.
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Ensure Commissioning & Qualification Plans, processes and procedures are compliant, reliable and fit for purpose.
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Manage support of Commissioning and Qualification activities to Operations.
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Represent Commissioning & Qualification (directly or indirectly) in CAPEX projects.
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Represent Galderma towards suppliers of equipment and systems (e.g., Commissioning and Qualification processes).
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Establish and maintain potential relationships with all stakeholders within and outside the organization.
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Align with Global Engineering and Quality teams regarding solutions, processes etc.
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Participate in Change Control, Deviation management and CAPA processes, as needed
Skills & Qualifications
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Master or bachelor's degree in Bioscience, Industrial sciences, Quality or equivalent experience/qualification
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Minimum of 8 years' experience in qualification and verification
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Previous experience within GMP and Part 11 or alternatively from a related regulatory industry
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Team management experience or very good leadership capabilities
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Professional level in Swedish and English
What we offer in return
You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
As Galderma's Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from research and development to production and marketing. 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.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2025-01-07
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR012386".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Kontakt Galderma
karine.legerot@galderma.com Jobbnummer 9065007