Kells Alliance Consulting, LLC

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Kells Alliance Consulting, LLC Kells Alliance Consulting, LLC offers real-world experience and knowledge gained from over 30 years in the pharmaceutical industry.

Skilled, versatile pharmaceutical professional with over 30 years in Brand and Generic companies involving ANDA, NDA and 505(b)(2) filings. Core competencies include:
* Proven results in creating GMP compliant and efficient analytical laboratories (R&D and QC)
*Strong positive compliance record with FDA and DEA.
*Extensive experience with CMC, OOS Investigations and CAPA.
*Quality System, SOP and

system design for FDA-GMP-ICH compliance and efficiency
*Development and validation of useful, transferable analytical test methods for QC.
*Technical Writing
*Rapid transfer of analytical test methods to commercial laboratories.
*Strong staff development through training and mentoring.
*Able to direct and motivate people from diverse backgrounds.
*Adept at managing multiple priorities and resources to meet challenges of complex projects.

25/01/2017

Situations frequently arise in all companies where it makes good business sense to take on a consultant / technical writer for a short period to deal with a problem or extra workload. As an experienced professional, I can provide expertise in reviewing validation reports, SOP's, test methods, Investigation reports, CAPA reports as well as drafting these documents as well. I can provide a second pair of eyes for dealing with a problem and can troubleshoot analytical testing procedures and administrative systems to provide the necessary solutions.

All this can be provided on a short term basis without the cost of taking on additional permanent staff. Call 203.417.1700 or email [email protected] to discuss how I can serve you.

29/12/2016

Experienced professional in Investigations, Reviewing, Validation, OOS, CAPA, SOP, CMC, Technical Writing, Auditing, FDA Inspections, R&D, QC/QA, Analytical Labs, ANDA, NDA. Available for short / long term assignments. Contact John Feeney at [email protected] or 203.417.1700.

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