Sökresultat för "EU GMP"

SallyQ AB

We're looking for a passionate and driven Senior Manufacturing Scientist – Aseptic Processing to join our Manufacturing Science & Technology (MS&T) team in Uppsala and play a critical role in ensuring the robustness, compliance, and continuous improvement of our aseptic manufacturing processes. At Galderma, we're not just offering a job, we're inviting you to be part of something bigger. About the Role You serve as the site's subject matter expert for aseptic manufacturing and contamination control, providing scientific and technical leadership across critical aseptic operations. You work cross-functionally to support routine operations, troubleshoot complex process challenges, lead investigations, and drive continuous improvement. A key part of the role is leading the site's media fill program and contamination control strategy, and ensuring compliance with evolving regulatory expectations, including EU GMP Annex 1 and global health authority requirements. Key Responsibilities Provide scientific oversight and technical expertise across aseptic manufacturing operations, including compounding, filtration, and filling processes. Lead the site's media fill / Aseptic Process Simulation (APS) program: design, execution, evaluation, reporting, and timely CAPA implementation to strengthen sterility assurance. Lead and support the Contamination Control Strategy (CCS) through scientific risk assessments spanning facility design, HVAC, environmental monitoring, cleaning and disinfection, and aseptic practices. Lead complex deviation investigations, root cause analyses, and CAPA activities related to aseptic processes. Design and evaluate smoke studies to verify airflow performance and first-air protection. Act as a trusted SME in audits, inspections, technology transfers, process improvements, and the implementation of new manufacturing technologies. The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week. Your Profile You're a curious, proactive, and scientifically minded professional who enjoys solving complex challenges and driving improvement in highly regulated manufacturing environments. You take ownership naturally, influence stakeholders with confidence, and navigate complexity while keeping compliance and continuous improvement front of mind. Qualifications Bachelor's, Master's, or PhD in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline, with several years of experience in a biopharmaceutical or other highly regulated manufacturing environment. Strong expertise in aseptic processing, contamination control, media fills, and sterility assurance principles within GMP-regulated operations. Experience with EU GMP, Annex 1 requirements, and regulatory expectations for sterile manufacturing. Proven track record leading deviation investigations, root cause analyses, and CAPA implementation. Excellent analytical, problem-solving, and technical writing skills. Strong stakeholder management and collaboration across multiple functions. Ability to independently manage complex projects and drive continuous improvement initiatives. Application If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ, the skin, meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Our site in Uppsala is Galderma's Global Center of Excellence for Aesthetics, home to over 800 professionals working across R&D, manufacturing, clinical development, and commercial functions. Here, cutting-edge science meets world-class manufacturing, creating an environment where innovation moves rapidly from concept to patient impact. As a Senior Manufacturing Scientist – Aseptic Processing, you'll influence critical manufacturing processes, contribute to regulatory excellence, and play a direct role in delivering high-quality products to patients around the world, joining a collaborative and highly skilled team where your expertise is valued and your ideas are heard.

SallyQ AB

The role We call ourselves a 60-year-old startup. Decades of scientific heritage, paired with the speed, ambition and hands-on energy of a company being built from the ground up. Right now, we're scaling manufacturing fast, and that means the way we assure sterility needs to scale with it. We're looking for a Sterility Assurance Lead who wants to own that agenda from day one, not just maintain a system, but shape how sterility assurance grows alongside the site. You will own and drive the site’s sterility assurance strategy. This role ensures compliance with global regulatory requirements and serves as the SME for contamination control, aseptic processing, and sterilization validation. Key Responsibilities Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS) in line with EU GMP Annex 1 and global standards. Oversee environmental monitoring, cleanroom qualification, and aseptic practices. Review sterilization validations and lead media fill programs. Drive contamination risk assessments, investigations, and CAPAs. Act as SME during audits and inspections. Provide training and mentorship in sterility assurance best practices. The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week. Your Profile You are a highly motivated sterility assurance professional with a strong quality mindset and a passion for patient safety. You combine deep technical expertise with leadership capabilities and are comfortable acting as a site Subject Matter Expert. You're energized rather than unsettled by a fast-scaling environment, you bring a proactive, solution-oriented approach that lets you spot risks early, drive improvements, and push operational excellence forward even as priorities shift. You thrive in a collaborative, cross-functional environment and can communicate complex technical topics clearly to both technical and non-technical stakeholders. You're confident leading investigations, mentoring colleagues, and driving initiatives that strengthen contamination control and aseptic manufacturing performance, and you see this growth phase as a chance to grow your own scope right along with it. Requirements Bachelor's or Master's degree in Microbiology, Biotechnology, Pharmacy, or another relevant life science discipline. 8–12 years of experience in sterile manufacturing, microbiology, or sterility assurance within the pharmaceutical, biologics, or medical device industry. Proven experience working in GMP-regulated environments and supporting regulatory inspections and audits. Hands-on experience with contamination control strategies, environmental monitoring programs, and aseptic manufacturing operations. Skills Deep technical expertise in aseptic processing, sterilization technologies (moist heat, dry heat, filtration), and microbial contamination control. Strong knowledge of cleanroom operations, HVAC qualification, isolators/RABS, and environmental monitoring systems. Solid understanding of EU GMP Annex 1 requirements and familiarity with global regulatory expectations (FDA, EMA, PIC/S). Experience performing risk assessments using tools such as FMEA, HACCP, or similar methodologies. Strong analytical mindset with the ability to interpret data trends and drive continuous improvement initiatives. Excellent documentation skills and a structured approach to problem-solving and investigations. Strong communication and collaboration skills with the ability to influence cross-functional teams. Application If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

Professionals Nord Örebro AB

Founded in 1986 by Karl Leif Torbjörn Marklund in Kumla, Sweden, Legosan AB has been a trusted partner in contract manufacturing for four decades. Initially focused on dietary supplements, we expanded into pharmaceuticals in 1998, becoming an authorized manufacturer of medicinal products. ​ Today, as part of the Wellma Group (https://www.wellma.com/), we offer a full range of custom manufacturing services tailored to meet the specific needs of each client. ​ Our modern facility is GMP-certified under EU regulations and licensed by the Swedish Medical Products Agency (Läkemedelsverket) for the manufacture of medicinal products. ​ For dietary supplements and food-grade products, we operate in compliance with HACCP requirements and hold certifications to internationally recognized quality standards, including IFS Food — a GFSI-recognized scheme developed by European retailers — and NSF/ANSI 455-2 GMP, considered the gold standard for dietary supplement manufacturing in North America. ​ At Legosan AB, we are committed to quality, regulatory compliance, and environmentally responsible practices — delivering reliable, high-quality manufacturing solutions that meet the evolving needs of our clients. Legosan befinner sig i en spännande utvecklingsfas och söker nu ytterligare en Qualified Person (QP) som vill vara med och vidareutveckla företagets kvalitetsarbete. Här erbjuds du en nyckelroll i en verksamhet där du får stort inflytande, korta beslutsvägar och möjlighet att vara med och påverka både arbetssätt och processer. Varmt välkommen med din ansökan! Information om tjänsten Professionals Nord söker i samarbete med Legosan en Qualified Person (QP). Legosan är ett svenskt företag som utvecklar och tillverkar kosttillskott och läkemedel med höga kvalitetskrav och ett starkt fokus på långsiktighet, kvalitet och kundnytta. Tjänsten är en direktrekrytering vilket innebär att rekryteringsprocessen sker genom Professionals Nord och att du anställs direkt hos Legosan. Du erbjuds En nyckelroll med stort ansvar och möjlighet att påverka verksamheten Möjlighet att utveckla och förbättra kvalitetsprocesser i en växande organisation En verksamhetsnära roll med korta beslutsvägar Ett bolag med hög kompetens, stark kvalitetskultur och engagerade kollegor Möjlighet att växa tillsammans med verksamheten och på sikt utveckla team och ansvar Arbetsuppgifter Som QP har du det övergripande ansvaret för att säkerställa att verksamheten uppfyller gällande kvalitets- och myndighetskrav. Rollen innebär ett nära samarbete med flera delar av organisationen och ett aktivt arbete med att utveckla och säkerställa effektiva kvalitetsprocesser. Dina huvudsakliga arbetsuppgifter innefattar: Ansvara för och säkerställa GMP-efterlevnad Granskning och frisläppning av batchdokumentation Underhåll och vidareutveckling av företagets kvalitetssystem Hantering av avvikelser, CAPA och förändringsärenden Planering, genomförande och uppföljning av interna och externa revisioner Framtagning och uppdatering av styrande dokument, rutiner och processer Vara ett kvalificerat stöd till organisationen i kvalitets- och regulatoriska frågor Vi söker dig som Har en relevant akademisk utbildning inom farmaci, kemi, kemiteknik eller annat naturvetenskapligt område som uppfyller kraven för att verka som Qualified Person Har erfarenhet från läkemedelsindustrin och arbete i GMP-reglerad verksamhet Har erfarenhet av kvalitetsarbete, QA, validering och produktion.  Har mycket god förståelse för regulatoriska krav och kvalitetssystem Kommunicerar obehindrat på svenska och engelska i tal och skrift Det är meriterande om du har tidigare erfarenhet av arbete som QP eller batchfrisläppning, men vi välkomnar även dig som har rätt utbildningsbakgrund och erfarenhet för att utvecklas in i rollen. Personliga egenskaper Vi tror att dina personliga egenskaper är avgörande för hur väl du kommer att trivas hos Legosan. För att lyckas i rollen ser vi att du är en strukturerad och kvalitetsmedveten person som trivs med ansvar och självständigt arbete. Du har ett prestigelöst förhållningssätt, tycker om att samarbeta med andra och motiveras av att skapa ordning, kvalitet och långsiktiga förbättringar. Vidare är du lösningsorienterad, noggrann och trygg i att fatta beslut i frågor som rör kvalitet och regelefterlevnad. START: Enligt överenskommelse OMFATTNING: Heltid STAD: Kumla URVAL: Sker löpande KONTAKT: Professionals Nord