EPM Scientific’s Post

⭐ Why consider a career in Quality Assurance? ⭐ Let's delve into the critical domain of Quality Assurance within the medical devices and pharmaceutical sectors. Precision, impact, and a commitment to innovation characterize our work. Quality Assurance functions as the guardian of product integrity, ensuring each release contributes to global healthcare excellence. This isn't merely a job; it's a career with a distinct purpose. Collaborating seamlessly with R&D, manufacturing, and regulatory affairs, to play an integral role in shaping the landscape of life sciences. Every day in Quality is dedicated to achieving perfection and overcoming complex challenges. It's a professional arena where continuous learning is the norm, staying abreast of industry trends and adopting cutting-edge technologies. Joining the Quality revolution means becoming part of a career where your impact is substantial. It entails contributing to a journey that elevates the standards of excellence in medical devices and pharmaceuticals. Are you prepared to be a driving force in an industry that holds immense significance? 🏆💼 #QualityAssurance #LifeSciences #CareerExcellence #MedicalDevices #Pharmaceuticals #QualityMatters

Very Interesting position

Working as Validation Manager in Pharmaceutical, Biotech, and Medical Devices is not an easy job. You need to be an expert in Business Analysis to understand the requirements of the project or the organization, you need to be an expert in Quality Assurance to align with QMS, policies, and standards, and lastly and you need to be an expert in Technical matters. For all of this expertise, one key element to become successful is COLLABORATION. Through collaboration, you can be able to find out solutions, and better understand the project, problem, and subject. #BusinessAnalysis #Validation #QualityAssurance #TechnicalSupportAnalysis #ProjectManagement #JobSeeker

Ensuring Precision: The Essence of Equipment Qualification in Technical Services ⚙️ In the pharmaceutical realm, equipment qualification is the backbone of quality assurance. It's about meticulously verifying that every piece of machinery operates precisely as intended, leaving no room for error. Key Takeaways: Accuracy Matters: Reliable equipment leads to reliable results. Qualification ensures accuracy in every step of the manufacturing process. Regulatory Compliance: Compliance isn't optional—it's mandatory. Equipment qualification aligns with stringent regulatory standards to uphold product integrity. Proactive Prevention: By identifying and addressing potential issues early on, qualification prevents costly disruptions and safeguards product quality. Let's stay vigilant in our pursuit of precision. Quality starts with qualified equipment. #TechnicalServices #Pharmaceuticals #EquipmentQualification #QualityAssurance #LinkedInPost"

Happy Wednesday! 😄 I hope everyone is having a great week so far. I have multiple Engineering, project management and a Regulatory affairs role available. Please let me know if you are interested in learning any more about any of these opportunities! 🔬 ⚗ #engineering #medicaldevices #pharma #biotech #regulatoryaffairs #projectmanagement #pharmaceutical #engineering

Involvement with customers in the pharmaceutical machinery industry typically includes several key aspects: 1)Needs Assessment 2)Understand the specific requirements of the customer. 3)Evaluate the customer's production goals, budget, and regulatory 4)compliance needs. 5) Knowledge sharing 6) Tailor machinery to meet unique customer specifications. 7) Collaborate on design modifications and special features. 8) Support customer for process development to meet or to achieve more. 9) Regulatory Compliance Assistance: Ensure machinery meets all regulatory standards (e.g., FDA, UKMHRA, EU). Provide documentation and support for validation and qualification processes. 10) Build long-term relationships through consistent communication and support. 11) Engage in collaborative R&D projects to develop new solutions. This comprehensive approach helps in building trust, ensuring customer satisfaction, and fostering long-term partnerships. #pharmaceuticals #pharma #randd #production #support #maintenance #engineering #sales #machinery #machine #customer #relationship #projects #knowledgesharing

Fractional services can be an effective option for those looking to fill key roles or expand their organization. Do you need a head of Quality or have upcoming projects? We're here to support you. Lets connect Please message me here on LinkedIn, or send me an email. rwelsh@qualityandcompliance.com You can also give me a call: 905-363-1182, Ext. 278 #pharma #healthcanada #regulatorycompliance

Regulatory hiring is ramping up as the year winds down! 2024 will be a year filled with Burgeoning Opportunity My clients all have exciting developments in their respective pipelines and will be opening corresponding Regulatory opportunities headed into next year. Many of my connections from the last 5 years of Regulatory Affairs focused Talent Consulting and I are setting up conversations as 2023 comes to a close and with 2024 goals in mind. Reach out and we can reconnect! #RegulatoryAffairs #Hiring #Regulatory #Hiring #Hiring2024 #Opportunity #TalentAgent #TalentConsultant #Pharmaceutical #PharmaceuticalIndustry #DrugDevelopment

☝️1️⃣🅰️Planning and strategy play crucial roles in ensuring the success and compliance of CQV activities. Here's a breakdown of planning and strategy considerations in CQV where IncepBio can help: 🛄Planning in CQV: Project Scope Definition: Clearly define the scope of the project, including all systems and components that require commissioning, qualification, and validation. 🔍Risk Assessment: Conduct a thorough risk assessment to identify potential hazards, critical processes, and areas of concern. 📚✅Regulatory Compliance: Understand and comply with relevant regulatory requirements, guidelines, and standards (e.g., FDA, EMA, ICH). 🫡Resource Allocation: Allocate resources, including personnel, equipment, and time, based on the complexity and criticality of the systems being validated. 📝Documentation: Develop a comprehensive documentation plan, including protocols, reports, and standard operating procedures (SOPs). 📩📢📳Communication Plan: Establish a communication plan to ensure effective collaboration between different departments, stakeholders, and project teams. 🤔Strategy in CQV: 🗒️Validation Master Plan (VMP): Develop a Validation Master Plan that outlines the overall validation strategy, including the approach to commissioning, qualification, and validation activities. 📊Risk-Based Approach: Adopt a risk-based approach to focus efforts on critical systems and processes. 📶Phased Approach: Implement a phased validation approach, breaking down the overall validation process into manageable stages. 🏗️Change Control: Implement a robust change control strategy to manage any changes to the systems or processes during and after validation. 📚Training and Qualification: Develop a strategy for training personnel involved in CQV activities. 🔄Continuous Improvement: Incorporate a strategy for continuous improvement, including feedback loops, lessons learned, and updates to validation procedures based on experience. Have a discussion 📞 with IncepBio or go and visit 👀 www.incepbio.com and get a clear idea 💡💭. #audit #support #pharmaceutical #biopharmaceuticals #biotechnology #medicaldevices #regulatorycompliance #suppliermanagement #internalaudit #continuousimprovement #training #documentation #improvement #technology #automation #dataintegrity #guidelines #manufacturing #qc #qa Ajith K Jose ANAND R PILLAI Asish Kumar Ambarish Ghali Prashanth Hugar

Regulatory compliance is a critical aspect of cleanroom design and construction, especially in industries such as pharmaceuticals, biotechnology, and semiconductors, where standards are stringent and constantly evolving. At AdvanceTEC, we specialize in navigating these complex regulatory landscapes, ensuring that every project we undertake not only meets but exceeds the necessary compliance standards. Our team stays abreast of the latest regulatory changes and leverages their deep understanding of industry-specific requirements to guide our clients through the compliance process. From the initial design phase to construction and validation, we ensure every detail adheres to the relevant standards, including ISO classifications, cGMP guidelines, and other regulatory frameworks. Our expertise in regulatory compliance offers our clients several advantages. It minimizes the risk of project delays and cost overruns associated with compliance issues, ensures the safety and efficacy of the products manufactured within our cleanrooms, and ultimately supports our clients' goals of bringing innovative and life-saving products to market. With AdvanceTEC, you can trust that your project is in expert hands, leaving you free to focus on what you do best—innovating and pushing the boundaries of what's possible in your field. #RegulatoryCompliance #Expertise #CleanroomConstruction