ExperiencedQuality/Validation Engineerwith hands - on experience in various type ofmedicaldevicesand systems (class I, II, III) & pharmaceutical products, development, manufacturing, new product introduction, process validation.
Extensive exposure to production areas, compliance requirements, standard operational procedures, audit protocol development and execution andCAPAinvestigations.
Proficient in all applications of MS Office, including Minitab, Taylor’s Normal Distribution Analyser, Gauge R&R, Agile and many other useful software programs.
In-depth knowledge of Process and Cleaning Validation, equipment qualification, cGMP, GLP, FDA regulations and ICH guidelines
Lean Six Sigma, pFMEA, Risk Management
Commissioning and De-commissioning
Change Control, Deviations and CAPA
Analytical Techniques - Chromatography (GC, HPLC, RPLC), Spectroscopy (UV - Vis and IR).
Strong analytical, validation, technical writing, documentation, communication and team management skills
Ability to operate independently as well as team, Document archiving, Institutional regulatory compliances
Project Management Skills, ability to meet the project deadlines