Microsoft Office Quality

Quality Auditor / Analytical Data Reviewer

November 30, 2016

Volt Workforce Solutions,

I would like to be considered for the position of Quality Auditor/ Data Reviewer in New Brunswick, NJ. I am a perfect match for this position since I am currently working in a similar role at a Regulated Pharmaceutical company engaged in the contract manufacture of OTC Products. At present, I am managing Pharmaceutical Quality Systems, mainly Audit Program for conducting Internal Audits as well as External Vendor Audits, hosting Third Party Audits requested by our clients, keeping GMP functions of manufacturing operations, QC Laboratory, and facilities in compliance with company policies and requirements of regulatory agencies. I have worked at contract testing lab, Lancaster Labs, as Senior Data Reviewer. I come with a solid background in Biochemistry, Chemistry, & Biological sciences and hands on experience in Review of Pharmaceutical Technical Documents, Laboratory Records, and Production Batch Records and controls. Additionally, I am a Certified Quality Auditor (ASQ:CQA), and Certified Pharmaceutical GMP Professional (ASQ:CPGP).

I have worked for major pharmaceutical companies engaged in commercial manufacture of branded prescription medicines, contract testing, and contract manufacture of healthcare products at various levels of responsibility. Majority of my career, I managed the Quality Functions and operations of Analytical Laboratories engaged in cGMP testing of pharmaceutical samples, method development, and method validation to support the development and commercial manufacture of pharmaceuticals. I have managed the elements of quality system, specifically, change control, internal auditing/gap analysis, participating in external audits, writing responses to audit findings and observations (Form 483), equipment qualification and preventive maintenance, identifying OOS test results and non-conforming GMP issues, conducting root cause analysis of deviations and non-conformities and following with implementation of CAPA, when necessary. My strengths are writing, and reviewing the pharmaceutical laboratory and manufacturing records, technical GMP documents (SOPs, STMs, Manufacture Batch Records, Stability Protocols/Reports, product specifications, Certificate of Analysis, Method Developments reports, method validation protocols/reports), and GMP Compliance Auditing.

I am very flexible and can easily interface with personnel from different units of the organization. I am current with knowledge of principles of cGMP, ISO and USP standards, 21CFR, Parts 210, 211, 58, & 820, and relevant FDA, EU, and ICH Guidance documents, and have advanced level knowledge of Microsoft Office, statistics, and LIMS. I have great communication skills, both oral as well as written. I am available immediately, and I live locally in Morris County, NJ. Please contact me for any additional information you may need.

Thanking you, Dalip S. Gill

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