Dedicated and detail-oriented Quality Assurance professional with one year of experience in Good Distribution Practices (GDP). Proven track record in ensuring compliance with regulatory standards, conducting thorough inspections, and implementing effective quality control measures. Adept at identifying areas for improvement and driving continuous process enhancements. Possess strong analytical skills and a commitment to maintaining the highest standards of product safety and data integrity.
Computer proficiency in Microsoft PowerPoint, Ms office and Excel
Well known about NMR, Mass Spectroscopy, XRD, and Infrared Spectroscopy
Strong knowledge of GDP, GxP, cGMP and MHRA standards
Well-known about Temperature Mapping and Change Controls
Batch documentation Review and SOP procedures
Strong knowledge to deal with Product quality Complaints (PQC)
Knowledge of drug design and drug development of clinical trials
Having theoretical and practical knowledge of OOS, OOT, and CAPA
Knowledge of ICH guidelines
ALCOA and ALCOA plus principles (Data Integrity)
Formulation of syrups and tablets and other skin care products
Validation and qualification of analytical methods
Good manufacturing practice regulations (GMP)
Basic knowledge of regulatory affairs