Join Our Team as a QA Validation Specialist! 📍Multiple locations across Europe ⏱️ 6-month on-site role We’re on the lookout for experienced QA Validation Specialists to join us for several onsite roles across Europe, where you'll work on Risk-Based Qualification projects for our key clients. You’ll report directly to KPC’s Quality Assurance Validation team as part of the broader Commissioning & Qualification function. ✅Responsibilities: · Reviewing live documents (under execution) located within a paperless documentation system. · Conduct Quality Peer review/pre-approval and post-approval of protocols, CQTPs, test protocols etc,. · Maintenance of a strong Quality culture throughout the project through operational activities. · Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval of documentation from design to post execution. · Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations. · Ensure and participate in the Quality Assurance support to internal manufacturing and technical groups. · Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols). · Review and approve Validation protocols as required. (Examples include cleaning, process, and method validation). · Develop and report quality metrics such as punch list items/Non-conformances. 💡What We’re Looking For: · 3-5 years of hands-on experience in Quality/Validation, with a background in Drug Product and Drug Substance. Ideally with experience working in a C&Q environment. · Experience in biopharma industry, in a project leadership role. · Degree in Science, Engineering, or equivalent · Fluent in English; French would be a huge plus! Ready to embark on this career-changing journey? We’d love to hear from you! 👉 Contact Karolina at karolina.gorzewska@kpc-international.com for more info or to forward your CV. #QA #Vaildation #Pharma #WeAreHiring
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🚨Sr. Associate - Quality for Computer Systems Validation🚨 I'm on the hunt for a QA Professional for Automation to join Lillys innovative team in #Limerick at their new Manufacturing Facility. #Lilly #Limerick is all about revolutionizing healthcare through next-gen #biopharmaceuticals. As a 𝗦𝗿. 𝗔𝘀𝘀𝗼𝗰𝗶𝗮𝘁𝗲 - 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗳𝗼𝗿 𝗖𝗼𝗺𝗽𝘂𝘁𝗲𝗿 𝗦𝘆𝘀𝘁𝗲𝗺𝘀 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻, you'll be diving headfirst into the exciting world of maintaining product quality and regulatory compliance specifically for Lillys computer systems. 𝗬𝗼𝘂𝗿 𝗿𝗼𝗹𝗲? To work hand-in-hand with Lillys amazing cross-functional team, implementing quality standards, supporting audits, and driving those all-important continuous improvement initiatives. If you think you've got what it takes, here's a sneak peek at what you'll be diving into: 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗔𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲 𝗢𝘃𝗲𝗿𝘀𝗶𝗴𝗵𝘁: Developing and maintaining procedures, ensuring compliance, and making sure quality is at the heart of everything they do, especially when it comes to computer systems. 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: Keeping up to speed with industry regulations, assisting with inspections – you name it, you'll be on it, with a special focus on computer systems validation. 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗥𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴: Keeping those records shipshape and driving consistency across computer systems, ensuring they're fully validated and compliant. 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗜𝗺𝗽𝗿𝗼𝘃𝗲𝗺𝗲𝗻𝘁 𝗜𝗻𝗶𝘁𝗶𝗮𝘁𝗶𝘃𝗲𝘀: Optimizing Lillys systems validation processes. 𝗧𝗿𝗮𝗶𝗻𝗶𝗻𝗴 𝗮𝗻𝗱 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁: Sharing your own expertise and staying on the cutting edge of quality assurance. 🎓 Bachelor's degree or higher in Science, Engineering, Quality, or a related field. 💼 3+ years of QA experience in biotech, pharma, or medical device manufacturing. 🧠 Strong knowledge of cGMP, FDA regulations, and quality risk management, with a focus on computer systems validation. 🤝 Excellent communication skills and a knack for teamwork. 🔍 Detail-oriented with a passion for maintaining top-notch quality, especially in computer systems validation. If you're ready to take the leap and join a team that's making a difference or you're just intrigued by the above, click the link to have a look at the full, detailed job description here 👉 https://e.lilly/3IFCN22 #BiotechInnovation #QualityAssuranceExpert #qualityassurancejobs #QualityAssurance #ComputerSystemsValidation #Limerick #LimerickJobs #PharmaIreland #WeAreLilly Jordyn Wintczak Ailís Dwyer Louise Quirke Richard O'Sullivan Kevin McCarthy (Talent Sourcing - US and Irish Market) Laura Heald Shane Lee Sean Heffernan Eoin O'Donovan Meggan Tully Stephanie Morrison Louise Quirke Katie O'Connor Conor Cronin Sharon Kennedy Ouda Rukundo Assoc. CIPD Richard Neylon Shauna O'Donovan Karen R. Juliette Lewis Aoife O Driscoll Catherine O'Sullivan
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AQA (or Lab QA) vs IPQA in pharmaceutical 💊 Analytical Quality Assurance (QA) and In-Process Quality Assurance are two distinct approaches used to ensure the quality of products, services or processes. Analytical Quality Assurance (QA)✍️ 1. Focus: Analytical QA focuses on testing and evaluating the final product or service to ensure it meets specifications and requirements. 2. Timing: Conducted after the product or process is completed. 3. Methods: Sampling, testing and inspection. 4. Goals: Identify defects, determine compliance and provide confidence in the product quality. 5. Benefits: Efficient, cost-effective and suitable for high-volume production. In-Process Quality Assurance✍️ 1. Focus: In-Process QA focuses on monitoring and controlling the production process to prevent defects. 2. Timing: Occurs during production, in real-time. 3. Methods: Process monitoring, statistical process control and continuous improvement. 4. Goals: Prevent defects, reduce variability and improve efficiency. 5. Benefits: Reduces waste, improves yield and enhances overall process reliability. Key Differences🤔 1. Timing: Analytical QA occurs after production, while In-Process QA happens during production. 2. Focus: Analytical QA focuses on the product, whereas In-Process QA emphasizes the process. 3. Approach: Analytical QA is reactive, detecting issues after they occur. In-Process QA is proactive, preventing issues before they arise. Implementing Both Approaches🪝 1. Comprehensive Quality Strategy: Combine analytical and in-process QA for optimal quality control. 2. Risk Assessment: Identify critical control points requiring in-process monitoring. 3. Continuous Improvement: Analyze data from both approaches to refine processes. By integrating both analytical and in-process QA, organizations ensure robust quality control, minimizing defects and maximizing customer satisfaction. #AQA #IPQA #labQA #Quality #usfda #QC #pharma #qualityassurance #qualitycontrol #audit #Dhruvjayswal
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Interviews can be daunting, especially in the highly regulated world of Medical Device manufacturing. Here are my top 5 tips for candidates stepping into Quality Assurance (QA) roles: 1. **Know the Regulations**: Familiarize yourself with the relevant regulations such as FDA's Quality System Regulation (QSR), ISO 13485, and EU MDR. Understand how they impact QA processes. This knowledge not only demonstrates your expertise but also shows your commitment to quality and compliance. 2. **Speak the Language of Quality**: Be prepared to discuss key quality concepts like CAPA (Corrective and Preventive Action), risk management, validation, and verification. Articulate how you've applied these in past roles or how you would in hypothetical scenarios. 3. **Detail-Oriented Examples**: Bring specific examples of how your attention to detail has made a difference in past projects. Whether it's catching a documentation error or improving a testing process, these stories will illustrate your value to the team. 4. **Continuous Improvement Mindset**: Show that you're not just about maintaining standards, but also about raising the bar. Discuss how you stay updated with industry trends and how you've contributed to continuous improvement initiatives in the past. 5. **Soft Skills Showcase**: QA roles involve cross-functional collaboration, so highlight your communication and teamwork skills. Discuss how you've worked with other departments to ensure quality and compliance. Remember, it's not just about technical know-how; it's about fitting into a culture that prioritizes patient safety through rigorous quality assurance. Good luck! #QualityAssurance #MedicalDevices #JobInterviewTips
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🔍 Top Tips for QA Interviews in Medical Device Manufacturing 🔍 Interviewing for a Quality Assurance (QA) position in the Medical Device sector can be challenging, but with the right preparation, you can stand out. Here are my top 5 tips to help you succeed: 1. **Know the Regulations** ✅ Medical Device manufacturing is heavily regulated. Familiarise yourself with ISO 13485, FDA regulations, and any other relevant standards. Demonstrating your knowledge of these can show your commitment to maintaining high-quality standards. 2. **Highlight Your Attention to Detail** ✅ QA roles require meticulous attention to detail. Share specific examples from your past experiences where your keen eye caught potential issues before they became problems. This can illustrate your proactive approach and reliability. 3. **Understand the Product Lifecycle** ✅ Be prepared to discuss how QA fits into the entire product lifecycle, from design to post-market surveillance. Showing that you understand the big picture can set you apart from other candidates. 4. **Showcase Problem-Solving Skills** ✅ QA professionals often need to troubleshoot and resolve issues quickly. Highlight instances where you've successfully identified and addressed quality issues, explaining your thought process and the outcomes. 5. **Stay Updated with Industry Trends** ✅ The Medical Device industry is always evolving. Stay informed about the latest trends, technologies, and best practices. Mentioning recent advancements during your interview can demonstrate your enthusiasm and dedication to continuous learning. Remember, preparation is key. Good luck with your interview! If you have any questions or need further advice, feel free to reach out. #QualityAssurance #MedicalDevices #JobTips For more insights, visit hero.ie.
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❓ Should QA Write Departments' Work Instructions? ❓ When it comes to creating working instructions, it's often assumed that QA should take the lead. But is this the best approach for ensuring efficiency and accuracy? As the meme humorously suggests, it's time to reconsider who should be responsible for this crucial task. Here’s why departments should write their work instructions: - Subject Matter Expertise: Departments possess in-depth knowledge of their processes. This expertise ensures that instructions are accurate, detailed, and practical. - Efficiency and Relevance: When departments author their documents, the instructions are more relevant and easier to follow, leading to fewer errors and better adherence. - Empowerment and Accountability: By taking ownership of their documentation, departments become more accountable and empowered to improve their processes continuously. - Supportive Role of QA: QA should focus on reviewing and ensuring that the documents meet regulatory and quality standards, rather than being the primary authors. Let's rethink our approach to documentation. Empowering each department to create its own working instructions, with QA providing the necessary oversight, can lead to more effective and efficient processes. #GMPInsiders #QualityAssurance #ProcessImprovement #Pharmaceuticals #Documentation #Compliance #Efficiency #LifeSciences #WeeklyHumor
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As a recruiter specializing in quality assurance, I witness firsthand the invaluable impact QA professionals have on the pharmaceutical and life sciences industries. Their meticulous attention to detail, commitment to compliance, and dedication to upholding the highest standards play a pivotal role in ensuring product safety and efficacy. In a sector where precision is non-negotiable, QA experts serve as the guardians of quality, safeguarding patient well-being and industry reputation. Their work not only meets regulatory requirements but also fosters a culture of continuous improvement and innovation. From validating manufacturing processes to conducting critical inspections, QA professionals are instrumental in maintaining the integrity of every product that reaches the hands of consumers. Their role is not just about detecting errors but about preventing them, ultimately contributing to the advancement of medical breakthroughs and the well-being of countless individuals. To hiring managers and industry leaders, I emphasize the indispensable value of investing in top-tier QA talent. The right professionals can elevate operational excellence, mitigate risks, and drive sustainable growth in an increasingly competitive landscape. How do you believe the evolving regulatory landscape will shape the future of quality assurance in pharmaceuticals and life sciences? Let's start a conversation. #QualityAssurance #PharmaIndustry #LifeSciences
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Hello "Medical Device" "Recruiters"! 👋🏻 We bring top-tier engineering talent to elevate your upcoming projects! Our elite team is primed and ready to make a significant impact. Whether you need Packaging Engineers, Validation Experts, or Manufacturing Engineer, We've got it all covered. 🔺 Validation Engineer 🔺 Cleaning Validation 🔺 Packaging Engineer 🔺 CSV Engineer 🔺 Manufacturing Engineer 🔺 Process Engineer 🔺 Product Development Engineer 🔺 Quality Engineer Show your support by "liking" this post and We'll send you the "Hotlist" of our available consultants to keep you in the loop! Let's connect these experts with your "Corp" to "Corp" ("C2C") needs. Share your requirements with us at roy@wissenitgroup.com 📩 Connect with me, Srikar Reddy, for daily updates on consultant availability. Thanks & Regards Srikar Reddy Insight Sales Lead | WissenIt Inc Office: +1 (980) 381-4058 Ext: 662 #csv #csvengineer #validation #qualityanalyst #qa #pharma #recruiters #technicalrecruiter #21cfrpart11 #fda #medical #pharma #pharmaceutical #veevavault #hpalm #jira #gamp5 #trackwise #lims #c2c #regulatorycompliance #regulatoryaffairs #c2crequirements #corp2corp #open #regulatoryaffairs #quality #projects #packaging #medical #medical #consultants #writer #meddevice #medicaldevices #pharmaceutical #biotechnology #validation #cfr #riskanalysis #sdlc #changemanagement #urs #validationengineer #usa #uscitizens #greencard #experienced #pharmaindustry #medical #c2c #quality #qaengineer #validationengineer #validationconsultant #csv #medicaldevices #pharma #csvengineer #capa #gxp #gmp #fmea #eumdr #regulatorycompliance #iso #regulatoryaffairs #tester #EHS #Engineer #pharma #OPT #CPT #H1Bhashtag #H4hashtag #GChashtag #USChashtag #opentorelocate #hashtag #Medhashtag #pharma #hashtag #lifescience #hashtag #c2c
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good opportunity
Ashling Guthrie is seeking candidates for Quality & Validation roles ( permanent & contract) in various locations across Ireland. Here are a few of our featured jobs: 📍 Operations Lead | Dublin | https://lnkd.in/eyc_4Ahn 📍 Sterility Assurance Lead | Sligo | https://lnkd.in/eyQmyjaS 📍 QA Operations Manager | Sligo | https://lnkd.in/eGb9X3Ki 📍 Head of Quality | Midlands | https://lnkd.in/et7CDi7P Apply directly or if you can't quite see what you're looking for, there are more roles on our website https://lnkd.in/e4Jg895, or get in touch with Ashling directly as there are always more exciting opportunities opening 📱098-39159 📩 ashling.guthrie@teamhorizon.ie #qualityjobs #qajobs #validation #pharmajobs #lifesciences #teamhorizon
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opportunity
Dear Aspirants, We are having opportunity for a reputed pharma company POSITION - Asst. Manager - ITQA QUALIFICATION - MSc , Chemistry/M. Pharm . EXPERIENCE - 7+ years CTC RANGE - Max. In Btw 15 LPA JOB DESCRIPTION - Good experience should be in CSV , IT Compliance , Digital Compliance , Quality Auditing , R&D QA , QMS, Change Control , CAPA , Computerized Systems . Contact No & Whats App - 9737979902 Mail ID - workfromhome.virendra@gmail.com/hiring@bigpharmajobs.co.in
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Opportunity
Ask not what your network can do for you- ask what you can do for your network. Small/mid sized medical device company in the Boston area looking for a Director, QA & Regulatory Compliance. Someone out there needs a new position in these challenging times. Is it you? Someone you know? Contact me directly for details, or comment below with someone's name you're trying to support. Thanks!
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