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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

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