SUMMARY:

• 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
• CIP, COP/SIP
• 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

WORK EXPERIENCE:

Confidential

Quality Engineer

Responsibilities:

• Writing Installation, Operation & Performance Qualification Protocols.
• Execution of IQ, OQ & PQ with analysis of data & written Summary reports.
• Performed Measurement System Analysis on measurement equipment.
• Writing TMV protocols and performed Gage R&R, written summary reports.
• Update & review of SOPs & Work Instructions for the manufacturing processes.
• Risk Assessment and preparation, review & update of pFEMA for the Water Purification System & Cleaning Process.
• Performed thorough investigation, inspection and disposition of non-confirming products to support NCRs.

Confidential

Quality Engineer

Responsibilities:

• Providing support to quality and validation activities to the product transfer to other facilities.
• Preparation of Quality plans and Master Validation Plans as per 21 CFR 820 & ISO 9001.
• Risk assessment & preparation of pFEMA for all existing products.
• Preparation of comprehensive validation tracker spreadsheets.
• Preparation of process flow charts including all the fabricated parts and assemblies required.
• Preparation & execution of Validation protocols (IQ, OQ & PQ) for all existing products.
• Preparation & review of Validation Reports.
• Responsible for the GMP review of executed protocols.

Confidential, New Jersey

Quality Engineer

Responsibilities:

• Preparation of Technical report for cleaning validation
• Preparation and execution of protocols for cleaning validation of all existing products. (IQ, OQ, PQ)
• Execution of IQ protocols for EDM Machines (EDM RAM, EDM Wire).
• Writing and executions of OQ & PQ Protocols and Summary Report of CVD Process.
• Writing Retrospective Validation Protocols & Summary Reports of machining process
• Improving the manufacturing process and inspection methods for dental implants
• Preparation of comprehensive checklist to review IQ, OQ & PQ.
• Quality review of Validation Protocols & Validation Summary Reports.

Confidential

Project Team Member

Responsibilities:

• Execution of FMEA and Validation Master Plan
• Preparation of IQ, OQ, PQ & Validation protocols
• Preparation & evaluation of change control documents, SOPs & CAPA.
• Cleaning validation using TOC analyser and development of Swab sampling method
• Use of minitab to practice the statistical tools such as Gage R&R, Process control, Process capability, DoE.

Confidential

QA Validation Specialist

Responsibilities:

• Prepared and executed validation protocols like IQ, OQ, PQ of equipment
• Developed SOPs for the processes
• Prepared SOPs / LIR reports and maintained the logbooks with accuracy
• Performed calibration, validation and troubleshooting of various laboratory instruments such as
• Dissolution, pH meter to ensure compliance with cGMP.
• Investigated deviations and take corrective action to resolve the deviations
• Performed batch manufacturing record auditing
• Performed limit tests and assay of raw materials, excipients and finished products by dissolution
• Test, HPLC, FTIR, Wet chemistry, Karl fisher hardness and friability testing
• Equipment Qualification (Blender, Autoclave, Balances, Bench press)
• Experience with HVAC systems and sterilization equipment