Hemish Ilangaratne’s Post

The RA/QA Director didn’t get the resources they needed so they left. The company isn’t hiring a replacement straight away, so the team has to pull together. The Regulatory Manager has had to work ridiculous hours, working to tight deadlines, with even fewer resources. So they’ve put in their notice. The rather desperate counteroffer didn’t fly, it's not about the money, they will be leaving in 2 weeks. The Quality Manager and two Regulatory Specialists are now also actively looking. This. Is. All. So. Very. Avoidable. Cost, time, resources, impact on regulatory compliance, delays in product registrations, disruption to key processes, further staff turnover, and the blow to company culture when entire teams start to leave. Losing key people doesn't just disrupt compliance and deadlines—it shakes the foundation of the team and can affect the whole organisation. A high turnover rate creates instability, erodes trust, and undermines the culture that was built over the years. Morale dips, collaboration falters, and remaining employees question their own future. When teams feel undervalued and unsupported, they walk—and often take the best parts of the company’s culture with them. Had leadership listened to and trusted the RA/QA Director's advice about needing extra resources, all of this could have been avoided. Trust your experts, back them when it matters, and you’ll prevent these costly and disruptive outcomes from happening in the first place. #regulatoryaffairs #qualityassurance #medtech

Let’s start a discussion and sharing of insights and perspectives. Whether you are a Vice President of Laboratory Operations, Corporate Director of Quality, Laboratory Director, Quality Manager, Business Unit Manager or a Laboratory Supervisor what do you think? I have seen over my career and had discussions with colleagues that have witnessed a lack of understanding of or a diminished view of quality’s role within a testing laboratory. You see on occasion risky activities or practices undertaken that could have a negative impact on data quality and the customer. You see the rushing of CAPAs to be completed that result in the problem not being addressed. You feel that quality activities and positions are not adequately funded or supported by upper management. You see only supporting the bare minimum to maintain accreditation. Additionally, by some, the blaming of Quality Managers for ALL quality system failures. On the flip side, I have seen Quality Managers that only point out problems and act like QA Police. Where Quality Departments have not built a constructive relationship with Laboratory Operations. Where Quality practices and procedures are seen as not efficient and negatively impacting production. Basically, things are out of balance within some labs. So what are the solutions, what are the actions needing taken when these types of issues or lab environment presents itself? What can laboratory leadership do to change this situation when it exists. Your thoughts and comments are welcome and encouraged. Should this be a topic for candid discussion at testing lab industry conferences? Do you feel it is relevant today? Let’s start a discussion. Please share your thoughts. #laboratorymanagement #testing #qualitymanager #qualityculture #laboratory #accreditation #qualityassurance #labmanager

#OpportunityAlert: Know someone for this job? Could you tag them in the comments to share with them? #hiring #jobseekers #careerists #jobs #careers #jobopportunity #jobopportunities #careeropportunity #careeropportunities courtesy https://lnkd.in/eJFHduU

#OpportunityAlert: Know someone for this job? Could you tag them in the comments to share with them? #hiring #jobseekers #careerists #jobs #careers #jobopportunity #jobopportunities #careeropportunity #careeropportunities courtesy https://lnkd.in/eJFHduU

🌍💊 I became a compliance expert in the pharmaceutical industry by the age of 28, working in one of the world's leading firms. 👥🛠️ I was looking for the next move and my manager convinced me to wait and take on a new department, fill a gap from the recent FDA inspection, and build a team. 🌐📝 I had to train as a Lead Auditor, set up, and manage the systems of oversight for all outsourced activities globally. 🤔⏳ For 2 years I was in a whirlwind, everything was overdue when I started. 🧑🎓📋🔍 Using the skills I had developed during my MSc in Quality Management, I prioritized systems, product specifications, and agreements. 🤷♂️ Everything was going well: new products, line extensions, complaints resolved, and then I was called into an unplanned meeting. 🔴 Redundancy. They needed someone in my role who speaks German; I don't and had already decided there was no alternative role. 😶 At the end of the meeting, I was told I couldn't talk to anyone about it as HR was unavailable. 😵 I left completely bewildered by the whole process. 💼💸 I quickly found an alternative role but didn't check their financial status and was disappointed when they went insolvent. 🌟📚 I've experienced 5 redundancies in my career, the first was the worst, but my skills, qualifications, and experience allowed me to navigate the others easily. 🎯🏅 When I was 25, I set a goal to become a Qualified Person as it was the only role I could see on site which would always be in demand throughout the industry. 🚀📈 After 20 years as a QP, I have seen so many people not take the opportunities they could, not be considered because they haven't had the training. 🎓 I now offer training myself. 💬🤝 If you'd like to find out how I can help you enhance your skills, send me a message saying INFO, and let's discuss how I can support you.

🔍 A Day in the Life: Quality Assurance Manager in the Compliance and Regulatory Field 🔍 Ever wondered what a day looks like for a Quality Assurance Manager navigating the intricate world of Compliance and Regulatory affairs? 🌐 Here's a glimpse into my daily journey: Morning Routine: ☕️📊 - Kicking off the day with a strong cup of coffee, I dive into the latest regulatory updates. Staying ahead of the curve is crucial, so I scan through industry publications and updates from regulatory bodies. Team Collaboration: 🤝 - Engaging with my incredible team is a highlight, discuss ongoing projects, address challenges, and strategize on ensuring our products meet the highest quality and compliance standards. Regulatory Landscape Scan: 📰🌐 - The regulatory landscape is ever-changing. I spend time reviewing global regulations, ensuring our compliance strategies are not only current but also forward-thinking. Flexibility is key! Documentation and Audits: 📑🔍 - A significant portion of my day involves reviewing documentation and overseeing internal audits. Quality assurance is about meticulous attention to detail, and our documentation must align seamlessly with regulatory requirements. Stakeholder Collaboration: 🤝🌐 - Collaborating with regulatory agencies and external partners is a crucial aspect. Whether it's discussing product submissions or addressing inquiries, building strong relationships is paramount. Problem-Solving: 🧠💡 - No day is complete without a dose of problem-solving. Whether it's identifying root causes of non-compliance or strategizing on corrective actions, every challenge is an opportunity for improvement. Training and Development: 📚👩💼 - Investing in the continuous development of my team is a priority. We engage in training sessions, ensuring everyone is equipped with the latest knowledge and skills needed to excel in their roles. End of Day Reflection: 🌙📈 - As the day winds down, I reflect on the day's accomplishments and challenges. This reflection guides our continuous improvement efforts, ensuring that each day brings us closer to our quality and compliance goals. The life of a Quality Assurance Manager in Compliance and Regulatory Affairs is dynamic, challenging, and incredibly rewarding. Every day brings new insights and opportunities to contribute to the high standards our industry demands. How about you? What does your typical day look like in the regulatory landscape? Share your experiences below! 💬✨ #QualityAssurance #RegulatoryAffairs #Compliance #DailyRoutine #LifeInTheIndustry

Ever wondered how safe public health truly is with QA at the helm? You are in the right place. Let's delve into how the guardians of quality assurance ensure our collective health. Dive into Part 2 of 5 part QA Leadership Series … AND…. Don't miss this exclusive opportunity to get a QA job qualification for 70% off. Gain critical skills, stay ahead in the industry, and get a QA Job Qualification from ISO back company in the EU. Link: https://bit.ly/3tU8aSL 💖 Exclusive offer 70% discount. Limited time to 31-01-2024 💖 No time limit 💖 No experience necessary 💖 Start when you like 💖 Available 24/7 💖 Available of web and mobile What you get: ✅Lifetime access ✅Job Qualification ✅ Immediate start ✅All Course Content and Assessments ✅Included in the Pharmuni Talent Pool 🚀 Enroll Now and join a community of QA professionals committed to making a difference. Link: https://bit.ly/3tU8aSL Your journey to becoming a QA leader starts here. Let's revolutionize quality management together! #QAleadership #QualityAssuranceTraining #PharmaQuality #CareerDevelopment #JobQualification #ProfessionalGrowth #ISOcertified #QualityManagement #OnlineLearning #PharmuniCourses

Ever wondered how safe public health truly is with QA at the helm? You are in the right place. Let's delve into how the guardians of quality assurance ensure our collective health. Dive into Part 2 of 5 part QA Leadership Series … AND…. Don't miss this exclusive opportunity to get a QA job qualification for 70% off. Gain critical skills, stay ahead in the industry, and get a QA Job Qualification from ISO back company in the EU. Link: https://bit.ly/3tU8aSL 💖 Exclusive offer 70% discount. Limited time to 31-01-2024 💖 No time limit 💖 No experience necessary 💖 Start when you like 💖 Available 24/7 💖 Available of web and mobile What you get: ✅Lifetime access ✅Job Qualification ✅ Immediate start ✅All Course Content and Assessments ✅Included in the Pharmuni Talent Pool 🚀 Enroll Now and join a community of QA professionals committed to making a difference. Link: https://bit.ly/3tU8aSL Your journey to becoming a QA leader starts here. Let's revolutionize quality management together! #QAleadership #QualityAssuranceTraining #PharmaQuality #CareerDevelopment #JobQualification #ProfessionalGrowth #ISOcertified #QualityManagement #OnlineLearning #PharmuniCourses

Last week, I conducted a poll on the integration of regulatory affairs and quality operations in today's job market. The results revealed an interesting split. 57% of people expressed excitement about the broader impact, while 43% voiced concerns about the increased demands and expanded scope of responsibilities. The split highlights a key moment in the RA/QA market. On one hand, bringing together regulatory affairs and quality operations could streamline processes, boost compliance, and create a more unified approach to product quality. These in turn could spark innovation, speed up time-to-market, and ultimately benefit consumers. But we can't ignore the concerns people have. Combining these two key areas can mean heavier workloads, more complexity, and the need for professionals to quickly pick up new skills. As this interesting dynamic develops, it will be important to encourage open communication, offer continuous education, and invest in tools that boost efficiency, because finding the right balance will be key to making this integration a win-win for everyone involved. #RegulatoryAffairs #QualityOperations #IndustryTrends

👋 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