Experience

• 

  Spcal labs private limited

  Nov 2022 - now

  Calibration and validation engineer

  Dedicated and results-driven professional with a robust background in ensuring compliance with global regulatory standards, including FDA, GMP, ICH Q9, 21 CFR Part 11, ISO, and EUGMP guidelines. Proven track record in steering organizations through successful audits by regulatory bodies such as US FDA, MHRA, and NABL.📑 Regulatory Compliance Expertise:Adept at interpreting and implementing SOPs from FDA, GMP, data integrity, ICH Q9, 21 CFR Part 11, ISO, and EUGMP guidelines for Validation and Calibration. Strong emphasis on maintaining data integrity and adherence to stringent regulatory requirements.🛠️ Validation and Calibration Proficiency:Extensive experience in Compressed Air tests, Pure Steam tests, HVAC Validation, Thermal Validation, and mapping. Well-versed in Calibration of Mechanical, Thermal, and Electro-technical systems. Ensured adherence to company SOPs for handling instruments, work methodologies, safety procedures, and overall work practices.🔍 Quality Assurance and Auditing:Skilled in conducting quality audits, implementing corrective and preventive actions (CAPA), and navigating audits by regulatory authorities such as US FDA, MHRA, and NABL. Proven ability to maintain high-quality standards and compliance across all operations.🛠️ Technical Skills: Inventory Control and Management Quality Auditing and Process Validation Troubleshooting and Equipment Maintenance Change Control and Preventive Actions HVAC and Thermal Validation Calibration of Mechanical, Thermal, and Electro-technical systems Proficient in Microsoft Excel, SOLIDWORKS, and CATIA💼 Professional Attributes:Demonstrated ability to multitask and manage time effectively in dynamic work environments. Possess excellent analytical skills and a quick learner with a strong focus on preventive maintenance and quality control. Effective communication and presentation skills, with a commitment to continuous improvement. Show less