Bio

Accomplished, analytical, and highly organised QMS auditor and Regulatory affairs Management professional with over 8 years of frontline experience successfully overseeing the drug pipeline and legal compliance of a leading CRO and ensuring stringent quality standards across diverse pharmaceutical research and market analysis. Possess extensive knowledge of FDA, MHLW, CDSCO and EMEA regulations and broad experience with International standards ISO13485, ISO14155, ISO10993 and ISO17025 quality compliance. Demonstrated ability to organise and optimise workflow supported by extensive experience maintaining and updating Standard Operative Procedures. Leverage strong ability to proactively identify issues and orchestrate corrective measures and solutions. Open to learn further in regulatory, quality assurance and clinical trials arena. Available within a week due to contract terms as temporary employment aroused because of circumstances due to an increased workload. Specialties: Analytical laboratory expertise, Regulatory Affairs Management, Quality Assurance - CMC, Team & Workflow Management Scheduling, Data Analysis, DMF/DHF/RMF/FMEA, SOP/MFR/BMR/BPR, FDA & EMEA Standards, Compliance with Medicinal Products and Devices 21 CFR part 807, 812, 814, 820 and ISO-14155, ISO-13485, ISO-10993 & ISO-17025, IEC-60601-1 Compliance with Quality Systems ISO-9001, Compliance with ICH-GCP Practices, CAPA Reporting in QA