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KARCHENES
1-781-356-8461 rkdda218@westpost.net
79 Hayward St., Braintree, MA 02184
SUCCESSFUL QUALITY ASSURANCE PROFESSIONAL
Quality Assurance Professional with 15+ years holding positions of increasing re
sponsibility. Record of success in directing corporate GMP, GLP, and GCP progra
ms for successful companies (commercial products, contract drug synthesis, and c
linical supply manufacturer). Credited with developing and implementing process
es & procedures aimed at fueling exceptional productivity and efficiently remedy
ing production problems. Committed to building QA programs from ground up.
Reviewed GCP protocols and audited clinical sites for GCP compliance, review of
the IRB, inclusion / exclusion, case report form, etc.
Responsible for GMP, GCP and GLP internal audits from drug development to drug p
roduct. Worked with audited departments to correct deficiencies found.
Developed CAPA programs to ensure that corrective actions for Deviations, Audits
, Investigations and batch record observations were completed in a timely manner
. This resulted in a 25% drop in failures, audit observations and raised the int
egrity and quality of the products produced. This also helped save the company o
bservations by regulatory inspectors.
Developed Vendor Qualification Programs and Quality Agreements to ensure that CM
Os and CROs met cGMP and GLP standards resulting in better control of the produc
ts and data produced.
Developed and negotiated Quality Agreements with vendors to ensure understanding
of a vendor's quality responsibility.
Worked with Manufacturing to develop batch records and reviewed them for complia
nce with regulatory requirements and company policies.
Responsible for reviewing vendor batch records and working with vendors to resol
ve deviations and investigations.
Sat on several raw material committees where I worked with scientific personnel
to help develop and approve raw material specifications for GMP material
EXPERIENCE
GENZYME, Allston, Massachusetts (March 2010 - Present)
Compliance Specialist
Provide GMP review and approval of Cell Culture batch records.
Perform internal audits of Cell Culture manufacturing area and work with departm
ent management to resolve observations.
Review deviations and investigations and track corrective and preventive actions
using Trackwise.
Responsible for conducting GMP training with Cell Culture manufacturing staff.
EISAI RESEARCH INSTITUTE, Andover, Massachusetts (2001 - November 200
9)
Multimillion-dollar Drug Company and subsidiary of Eisai Corporate Laboratories
Japan.
Quality Assurance Manager (2005 to November 2009)
Provided effective leadership for all operations pertaining to Good Manufacturin
g Practices 21 CFR Part 210, and 211, ICH Q7A and Good Laboratory Practices 21 C
FR Part 58.
Coordinated Active Pharmaceutical Ingredients production compliance with federal
regulations for Phase I and Phase II clinical trials/toxicology studies for IND
submissions.
Teamed with Production, Analysis and Quality Control to resolve issues with out-
of-specification investigations and failures.
Oversaw and developed QA staff consisting of a GLP Specialist, GMP Specialist, V
alidation Engineer and a Document Control Coordinator.
Hosted corporate audits from our Japan colleagues twice a year. Was responsible
for audit observation responses.
Oversaw all elements of the companies GLP compliance program for Bio-Analytical
Laboratory. This includes:
Critical Phase audits and laboratory facility audits.
Inspection of final report.
Insertion and sign off of QA Statement and GLP Compliance Statement.
Inspection of raw data
Responsible for ensuring all GLP training.
Responsible for auditing of all GLP CROs.
Responsible for writing and approving all GLP compliance SOPs and other regulato
ry documents.
Responsible for all aspects of the companies GMP program. This includes:
Review and approval of Master Batch records.
Review and sign off of executed batch records.
Review, release of raw materials, intermediate and final products.
Conduct internal audits of all GMP areas.
Responsible for auditing of all GMP vendors and contract CROs.
Responsible for writing and approving all GMP compliance SOPs and other regulato
ry documents.
Managed Change Control Committee.
Member of several international project teams.
Member of regulatory audit teams.