Hire the Best Quality Assurance Specialist in Ra'S Al Khaymah, United Arab Emirates

As a Training Officer at Vertiv PB, I design and deliver training programs for employees and customers on various topics, such as quality management, process improvement, safety standards, and product features. I also evaluate the effectiveness and impact of the training interventions, and provide feedback and recommendations for improvement. I work with a global team of trainers and subject matter experts to ensure the quality and consistency of the training content and delivery. Before joining Vertiv PB, I spent over six years as a Senior Quality Assurance Specialist in the steel making and metal forging industry, working with Starwire (India) Limited and Metal Forging Industries. I ensured the quality and compliance of the products and processes, conducted internal and external audits, handled customer complaints, and led new product development engineering. I have multiple certifications in quality standards, such as ISO 9001, ISO 14001, ISO 45001, AS 9100, and ISO/IEC 17025. I also have an ASNT NDT Level II Certification in Liquid Penetrant Testing, a nondestructive testing method for detecting surface defects in metals. I hold a Bachelor of Technology degree in Mechanical Engineering from Deenbandhu Chotu Ram University of Science & Technology, and an Executive MBA degree in Operations from Symbiosis Centre for Distance Learning. I am skilled in quality control, quality management system, advanced Microsoft package, quality auditing, process control, complaint handling, failure mode and effects analysis, and PTC CREO5.0. I am passionate about learning new skills and technologies, and enhancing the quality and performance of the products and services that I work with.

As a highly experienced Quality Professional in the Pharmaceutical & Biotechnology industries, I possess a Master's degree in Microbiology and a deep understanding of cGMP regulations. With nearly 17 years of experience, I have established high standards of quality in Manufacturing and Quality Control divisions. I have extensive knowledge and hands-on experience in sterile, non-sterile, and biotech facilities, with a proven track record of driving team performance and leading internal audit teams to conduct Aseptic Process Simulations, GAP analysis, and internal and external audits. I am skilled in maintaining positive relationships with regulatory bodies and customers while ensuring compliance with their requirements. My expertise includes Quality Control activities, such as online document checking, handling of out-of-specification (OOS) and out-of-trend (OOT) results, and expertise in environmental monitoring and microbiological testing. I have conducted various analytical and microbial tests, including sterility, bioburden, microbial limit, and particulate matter analysis, and have experience working with moist heat sterilizers, dry heat sterilizers, HVAC systems, and incubators. My experience includes managing audits by regulatory agencies such as SFDA, MOH-UAE, USFDA, WHO, and TGA-Australia. As a Quality Professional with extensive experience in the pharmaceutical and biotechnology industries, I am committed to maintaining high standards of quality while ensuring compliance with regulatory requirements. Specialties: • Quality Assurance and Control in cGMP environment • Compliance Management for Quality Systems • Sterile, Non-Sterile, & Biotech Facility Knowledge • Internal Audit & Regulatory Compliance • Change Management and CAPA • Risk Management and Quality Risk Assessment • Qualifications and Validations for Equipment and Facilities. • Document Control & SOP Development. • Training & Development in Quality Practices • Continuous Improvement & Process Optimization • Proactive Approach to Quality Management • Adherence to Regulatory Guidelines and Standards • Environmental Monitoring and Microbiological Testing • Data Integrity and Documentation Practices • Quality Management System Implementation and Maintenance

2 years of experience with SFO Technologies pvt. ltd Cochin as a quality inspector. well experienced in functional testing of GE medical Boards, Final inspection of GE medical boards, PMS, Quality inspection, and Documentation.

I have experience in complex injectable Quality Assurance (cleaning validation & CSV)11+ years of experience in sterile formulation product like (suspension, emulsion, liposomes and microspheres, simple injection vial, ampoules, eye & ear drops, dry powder filing and PFS,) I am handling computer system validation , process simulation , subject matter expert in cleaning validation, process validation and equipment validation ,handling of QMS elements like change control and deviation management in JulpharPharmaceutical Ltd.

I graduated as a pharmacist from the German University in Cairo,Egypt in 2021. During my Bachelor’s studies, i aimed to expose myself to different pharmaceutical fields (Industrial QC & QA, Community pharmacy, clinical pharmacy) to grasp insights about various career options. Currently working as a part of QA operations team in non-sterile sites for the manufacturing of solids and liquids . Keen to boost my technical knowledge and to strengthen my hands-on experience to maintain high quality standards.

►I am an experienced Quality Assurance Team Lead with a demonstrated history of working in the pharmaceuticals industry. Skilled in Pharmaceutics, GHP, U.S. Food and Drug Administration (FDA), Total Quality Management (TQM), and Regulatory Affairs. Strong quality assurance professional with a diploma focused in Total Quality Management from Arab Academy for Science, Technology and Maritime Transport. . ► A Quality assurance officer with 4 plus years of experience in Pharmaceutical Industry- Skilled in QA Operations, Compliance, Audits, Significant international experience in multi-cultural and multi-national assignments. ► Experience in performing internal and external audits core experience of Quality Assurance, Quality Control, Production and Engineering. S

✔Karthikeyan Kesavalu., graduated as Masters in Pharmacy specialized in Pharmaceutical Analysis. ✔As a dedicated analyst currently engaged in testing of Raw materials, API and intermediate for Pharma & Biotech products. ✔Handling of sophisticated analytical instruments which comply with current regulations 21CFR part 11 such as HPLC, Dissolution tester, GC, AAS, FTIR, UV, Moisture analyzer, Refractometer, Polarimeter, Viscometer etc. ✔Performing test which comply with STP and specifications, monographs and in house methods. ✔Aware about the updated versions of USP, EP pharmacopoeia to impart on latest testing requirements. ✔Adhering to SOP, ALCOA principles, cGMP, GLP, GDP practices with real time reporting. ✔Performing the daily routine operations for instrument calibration checks for balances, pH Meter and due date reporting in advance if applicable. ✔Preparation of buffers, Mobile phase, reagents required for analysis. ✔Handling of lab incidents, OOT, OOS through eQMS (Ample Logic) to investigate with cross functional teams to determine the root cause. ✔Updating the data and results obtained through SAP operations. ✔Accompanied with colleague and supervisor for audit preparation. 𝐒𝐨𝐟𝐭𝐰𝐚𝐫𝐞 𝐒𝐤𝐢𝐥𝐥𝐬: ●Lab solution for Shimadzu HPLC. ●Total chrom for Perkin Elmer GC. ●CAMAG for HPTLC. ●LIMS, Ample Logic (e-QMS), SAP, MS Office. If you are looking for a highly skilled and experienced Quality Control Specialist with expertise in CAPA implementation, cGMP manufacturing, and QC analytical chemistry, I would be a valuable asset to your team. With a proven track record of driving process optimization, mitigating quality risks, and fostering cross-functional collaboration, I am confident in my ability to make significant contributions to your organization.

🔍 Lifelong Learner | Data Enthusiast | Quality & Strategy Advocate 🌟 Welcome to my professional journey! 🌟 📚 Lifelong Learning: I thrive on the pursuit of knowledge and continuous growth. My passion lies in harnessing the power of data analytics, data science, and artificial intelligence to drive Quality and Strategy Management to new heights. 📈 Quality & Strategy: I believe in the transformative potential of data-driven decision-making. My goal is to empower organizations to optimize quality and strategy through cutting-edge analytics and AI solutions. ⚖️ Work-Life Balance: Beyond the data-driven world, I'm a firm believer in the importance of work-life balance. When I'm not diving into data, you'll find me navigating obstacle courses, pounding the pavement on a run, strategizing over a game of chess, exploring nature through trekking, indulging in retail therapy (shameless shopping more likely) or exploring cultures through their gastronomic offerings. Balancing mind and body fuels my creativity and productivity. Let's connect and explore opportunities to learn, grow, and innovate together! 🚀