Engineer Quality

Summary:

•Experienced Quality/Validation Engineer with hands-on experience in various type of medical devices and 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 and CAPA investigations.

•Proficient in all applications of MS Office, including Minitab, Taylor’s Normal Distribution Analyser, Gauge R&R, Agile and many other useful software programs.

Skills:

•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

•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:

NuVasive Inc. West Carrollton, Ohio, USA. (Quality Engineer) Jan 2017 till present

NuVasive is an innovative global medical device company that is changing spine surgery with minimally disruptive surgical products and procedurally integrated solutions for the spine.

•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.

Hologic Inc, Bedford, Massachusetts, USA. (Quality Engineer) Aug 2015 to Sept 2016

Hologic Inc. is a developer, manufacturer and supplier of diagnostic and medical imaging systems (Class III), mainly focused on osteoporosis assessment, gynaecological assessment, X-ray for general radiography and mini C-arm imaging for orthopaedic applications.

•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.

Zimmer Inc., Parsippany, New Jersey, USA. (Quality Engineer) Oct 2014 to Aug 2015

Zimmer Inc. is a well reputed medical device (Class III) manufacturing company producing comprehensive range of orthopaedic products for joint replacement.

•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.

Stevens Pharmaceutical Research Center – Project Team Member Jan 2013 to May 2014

•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.

Ronak Life Care Private ltd., Patan India (QA Validation Specialist) Sept 2009 to August 2012

•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

Training Experience:

Ronak Life Care Private Ltd., Patan, India March 2009 to April 2009

Knowledge about drug usage and evaluation

Practical and theoretical training about tablet, capsule, oral liquids and ointments

Manufacturing process

Training in group quality control laboratory

Knowledge about packaging.

Education:

Master of Science in Pharmaceutical Manufacturing. Jan 2013 – May2014

Stevens Institute of Technology, Hoboken, NJ, USA GPA – 3.20/4.0

Certification:

Pharmaceutical Manufacturing Practices Jan 2013 - May 2014

Stevens Institute of Technology, Hoboken, NJ, USA

Bachelor of Pharmacy. Sept 2004 –August 2009

Rajiv Gandhi University of Health Science, Karnataka GPA- 3.1/4.0

India

References:

Available upon request

Contact this candidate