Quality Engineer Resume

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