Sarina A.’s Post

𝘿𝙤𝙘𝙪𝙢𝙚𝙣𝙩𝙖𝙩𝙞𝙤𝙣 𝙄𝙨 𝘾𝙤𝙢𝙥𝙡𝙚𝙩𝙞𝙤𝙣: 𝘼 𝙌𝙪𝙖𝙡𝙞𝙩𝙮 𝘾𝙤𝙣𝙩𝙧𝙤𝙡 𝙀𝙨𝙨𝙚𝙣𝙩𝙞𝙖𝙡. In the realm of quality control and assurance, the adage "𝐈𝐟 𝐢𝐭'𝐬 𝐧𝐨𝐭 𝐝𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐞𝐝, 𝐢𝐭'𝐬 𝐧𝐨𝐭 𝐝𝐨𝐧𝐞" underscores a fundamental truth: effective documentation is the backbone of any successful quality management system. Whether in pharmaceuticals, manufacturing, or any other industry, meticulous documentation practices are essential for ensuring accuracy, traceability and accountability of our processes. Recently, I encountered a challenging situation where I couldn't prove to my technical director that I had performed a critical task for a particular analysis. Despite completing the task, I had not documented it in the equipment usage logbook. This experience taught me the importance of thorough and immediate recording or documentation of our work in ensuring accountability and traceability. I've since implemented a more rigorous documentation process to avoid similar issues in the future. Learn from my mistake and always document your work diligently. How has the lack of proper documentation impacted your work or organization? Share your experiences and let's discuss the importance of documentation in ensuring quality and compliance. Have a wonderful week ahead. Still your girl, Jennifer Quality Control Expert ................................................. If you're just seeing my post for the first time, I'm Jennifer Assayomo, a Quality Control Expert in the pharmaceutical industry. I ensure pharmaceutical products meet the highest standards of quality and safety. With a background in Biochemistry and years of experience, I'm dedicated to upholding excellence in every aspect of my work. #Documentation #QualityControl #Compliance #20daylinkedinchallengewithhaoma

🔍 Quality assurance and quality control are essential pillars in ensuring superior product and service delivery. Quality assurance sets the stage by proactively preventing defects through robust processes and standards. On the other hand, quality control steps in to detect and correct any issues that slip through the cracks. 🚀 QA focuses on prevention, setting stringent guidelines to ensure products meet quality standards upfront, saving time and resources. QC, on the flip side, is all about correction, pinpointing and rectifying defects in the final product or service through inspections and tests. 🎯 Balancing prevention and correction is key for businesses striving for excellence in their quality management. By melding the strengths of both QA and QC, organisations can elevate their quality control processes and surpass customer expectations. 🌟 How do you harmonise prevention and correction in your quality management strategy? Share your insights below or personal message me, happy to deep dive! #QualityAssurance #QualityControl #QualityManagement #BizzMine #pharmaceuticals

Not entirely sure who needs to hear this but: - Quality Assurance (QA) - Quality Control (QC) - Quality Systems are not the same thing. I’ve noticed they're often swapped out for each other. Yet, they're in very different worlds. - QA ensures the consistent development and manufacture of products that meet set internal and external standards. - QC involves the techniques and activities used to meet and maintain the product's quality requirements. - A Quality System documents processes, procedures, and responsibilities for achieving quality policies and objectives. Sure, there’s a shared space—think of it as a Venn diagram with plenty of common ground. All three are vital to the lifecycle of products, from pharmaceuticals to medical devices. But let’s not confine all quality management to a single category. The fine print matters. Curious to explore the differences and why they matter? Let's unpack it below! 👇

Are you sure that your validated analytical methods are performing as expected over time? Are you aware of internal quality control and do you use quality control charts to monitor the performance of your analytical methods? Our recent blog post provides a short introduction into this topic: #pharma #quality #gmp

As regulatory affairs and quality management managers, you can simplify your compliance processes and stay updated with today's ever-changing regulatory landscape. Ensure successful product launches that meet all requirements with IMT's RAQA services. 𝗧𝗵𝗲 𝗣𝗮𝘁𝗵 𝘁𝗼 𝗦𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗖𝗲𝗿𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 Consulting in Quality Management Systems: Get expert advice on implementing and maintaining quality management systems. QMS Establishment: Assistance in setting up your Quality Management System. Product Development Consulting: Guidance through the product development process. Support for Verification & Validation: Help with product testing and validation processes. Technical Documentation: Comprehensive support in preparing and managing technical documentation. Submission: Assistance with regulatory submissions to ensure compliance. Market Surveillance and Maintenance: Ongoing support for market surveillance and product maintenance. Looking for a partner to solve your regulatory or QMS challenges? Don't delay — contact our experts today 👇 https://lnkd.in/dYCTNiKm #RegulatoryAffairs #qualitymanagement #raqa #medtech #MakingIdeasWork #EngineeringSolutions #medicaldevices

Quality Assurance: Beyond the Checklists As a BSc. Business Administration graduate currently serving my National Service at Entrance Pharmaceutical and Research Centre as a Quality Assurance Officer, I've come to realize that QA is more than just ticking boxes. It’s about ensuring that every product reflects the highest standards of excellence and integrity. In today's fast-paced world, where efficiency is key, the role of Quality Assurance goes beyond compliance. It's about fostering a culture of continuous improvement, where every stakeholder—from the factory floor to the executive office—plays a part in delivering quality. I'm excited to be at the forefront of this process, ensuring that every product meets the expectations of our customers and stands up to rigorous standards. Here’s to making quality our top priority in every step we take! 🚀 #QualityAssurance #NationalService #EntrancePharmaceuticalandResearchCenter #ContinuousImprovement

👋 Hey LinkedIn network! Ever wondered what a day in the life of a Quality Manager in the pharmaceutical world looks like? 🤔 Let me take you on a little journey! 🚀 First off, it’s not just about making sure our products are up to standard (though, yep, that’s a huge part!). It's more like walking a tightrope 🎪—balancing compliance regulations, safety protocols, and customer expectations, all while trying to keep our sanity intact. 😂 The day kicks off with a strong coffee ☕ because, trust me, you'll need it! The first task is diving into batch records, making sure everything complies with the latest rules, which, by the way, change more often than my phone’s software updates! 📱🌀 Then, it's onto quality checks and validations. It’s like being a detective 🕵️♀️—always on the lookout for any little hiccups or deviations. One minute you’re Sherlock Holmes, the next you’re managing a mini-crisis, solving puzzles, and making sense of chaos. 🔍🧩 And oh, the meetings! We coordinate with different teams to discuss quality improvements and manage to squeeze in answering a mountain of emails. 📧 It’s like our inbox has a life of its own—emails go in, but when they come out, it’s anyone’s guess! 😂 Despite the whirlwind, the satisfaction is immense. Knowing our work ensures that safe and effective medications reach those who need them makes it all worth it. 💊❤️ So, here’s a shoutout to all the Quality Managers out there, making the world a safer place, one compliance check at a time! 🌟 #PharmaLife #QualityManagement #QA #Pharmaceuticals #Compliance #DailyGrind #QualityAssurance #MakingADifference

❓ 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

🚀 Nailing your interview is key in landing that coveted Quality Assurance role in the Medical Device industry. Here are my top 5 tips to ensure you stand out: 1️⃣ **Understand the Regulations**: Medical devices are heavily regulated. Familiarize yourself with relevant standards like ISO 13485, FDA QSR, and EU MDR. Demonstrating your knowledge of these regulations shows you're ready to hit the ground running. 2️⃣ **Showcase Attention to Detail**: In QA, detail is everything. Share examples of how your keen eye has caught errors that others missed or how your meticulousness improved product quality in past roles. 3️⃣ **Process Improvement Mindset**: Employers love candidates who don't just follow processes but seek to improve them. Discuss a time when you optimized a QA process, reduced waste, or enhanced efficiency. 4️⃣ **Risk Management Skills**: Talk about your experience with risk analysis methodologies like FMEA. Highlighting your ability to anticipate and mitigate risks will show you're proactive and value-driven. 5️⃣ **Communication is Key**: QA roles often involve cross-departmental collaboration. Illustrate your ability to communicate effectively with both technical and non-technical stakeholders to ensure quality standards are understood and met. Remember, the Medical Device industry is about improving lives. Your role in QA is critical to ensuring products are safe and effective. Show your passion, your precision, and your drive to make a difference. #QualityAssurance #MedicalDevices #JobInterviewTips