I provide high-quality and comprehensive consulting services to pharmaceutical clients in various aspects of quality and compliance, such as regulatory inspection preparation, internal and vendor auditing, quality system implementation, and aseptic processing. With over 25 years of experience in the pharmaceutical industry, I have a strong knowledge of the global regulatory requirements and standards, including 21CFR-11/210/211, EU GMP, and ICH Guidelines. My mission is to help my clients achieve and maintain compliance, quality, and excellence in their pharmaceutical operations.
Pharma Gxp Compliance, Llc
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PresidentPharma Gxp Compliance, Llc Jul 2023 - Present
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Pharmaceutical ConsultantFreelance 1099/W2 Consultant Jan 2023 - Present
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Board MemberThe Steve Haydu St Patricks Lo Tide Fund Inc Jul 2019 - Apr 2024Volunteer Board Member for a non-profit organization providing support to local cancer warriors in need. -
Senior Quality SpecialistAlcami Corporation Nov 2020 - Dec 2022Provided senior level quality oversight and guidance for Manufacturing operations related to Equipment, Facility and Clean Utilities Qualification activities as well as Packaging and Oral Solid Dosage Forms Process Validation. Provided quality oversight and approval for Manufacturing related Change Controls and chaired the Site Manufacturing Change Control Review Board. -
Principal Quality Auditor, Global Quality And ComplianceBausch Health Companies Inc. Jan 2018 - Oct 2020Provided Compliance Support for Global Pharmaceutical, Medical Device and Distribution Sites by effectively conducting audits to identify deficiencies from Regulations and Corporate Standards and aiding in determination of effective CAPA plans to ensure deficiencies were mitigated and corrected. Member of the Global Aseptic Forum and considered a subject matter expert in Aseptic Processing. -
Pharmaceutical ConsultantIndependent Jun 2017 - Dec 2017Provided Quality consulting services to a Pharmaceutical API facility in Greenville, SC to ensure operations and procedures were up to date and compliant with FDA expectations and Corporate Standards.
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Regulatory Compliance ManagerAlcami Corporation Jul 2015 - May 2017Wilmington, North Carolina AreaLed and supported compliance initiatives for NC/SC sites related to inspection readiness, internal audits, client audits, vendor/supplier management and product complaint coordination to ensure compliance with 21CFR parts 210 & 211, EudraLex and other regulatory requirements.
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Sr. Corporate Quality SpecialistAaipharma Services Corp. Nov 2013 - Jul 2015Wilmington, North Carolina AreaLed client audits, internal audits, and supported compliance initiatives related to inspection readiness and Quality oversight/review. -
Specialist, Quality Systems And ComplianceMerck Feb 2012 - Oct 2013Durham, North CarolinaPerformed Internal Quality Audits and supported site Regulatory Inspections. Coordinated, and performed Mock Inspections and action item follow-up to help maintain the site in a permanent state of inspection readiness.
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ConsultantPharmamatrix Aug 2011 - Feb 2012Raleigh-Durham, North Carolina AreaProvided Microbiology/Environmental Monitoring consulting services to APP Pharmaceuticals. Performed Risk Assessments related to Environmental Monitoring, Disinfectant Efficacy and Regulatory Commitments. -
Sr. Principal Researcher (Manager), MicrobiologyEisai Us Apr 2008 - May 2011Managed group performing environmental monitoring of clean rooms and clean utilities. Supported start up of new parenteral facility (qualification of equipment, clean rooms, aseptic processing isolators, and clean utilities). Developed and implemented clean room/isolator EM qualification protocols and routine monitoring programs. -
Sr. Group Leader/Group Leader, Aseptic Operations (Environmental Monitoring)Dsm Pharmaceuticals Nov 2002 - Apr 2008Managed group performing environmental monitoring of clean rooms (including room monitoring, data review, investigation of excursions, data trending, media fill inspection oversight and gowning qualifications).
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Sr. Quality Associate/Quality Associate Iii Qa/Regulatory ComplianceDsm Pharmaceuticals Jun 2001 - Nov 2002Actively participated in Regulatory, Client and Internal audits in a variety of roles. Participated in investigations related to audit findings and verified acceptability of CAPA in response to audit findings.
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Control Scientist Ii/Control Scientist I, MicrobiologyCatalytica Pharmaceuticals 1996 - 2001Performed Microbiological testing of clean room environments, finished products and raw materials.
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Control Scientist/Lab Analyst IiGlaxo Wellcome (Formerly Burroughs Wellcome) 1994 - 1996Provided support to laboratory groups. Peformed Microbiological testing of clean room environments and finished products.
Karen Parrish Education Details
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Biology, Psychology (Second Major)
Frequently Asked Questions about Karen Parrish
What company does Karen Parrish work for?
Karen Parrish works for Pharma Gxp Compliance, Llc
What is Karen Parrish's role at the current company?
Karen Parrish's current role is Pharmaceutical Quality/Compliance Consultant.
What schools did Karen Parrish attend?
Karen Parrish attended East Carolina University.
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Karen Parrish
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