Professional Documents
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PROFILE
Highly experienced Quality Assurance/Regulatory Compliance professional with bro
ad knowledge of pharmaceuticals, class II/III medical devices, dietary supplemen
ts, and consumer products. Experience includes dosage forms such as soft gels,
tablets, liquids, semi-solids, ointments, creams, and vaccines. Compliance exp
erience includes FDA GMPs (110/211/820) and part 11; Consent Decree Management;
ISO9000; ISO13485; DEA; HACCP.
Technical skills include microbiology laboratory management; R&D QA; manufacturi
ng QA; CMC management; global license conformance; technical transfer and new pr
oduct launch; equipment qualification and process validation; batch record audit
and product release; internal and supplier auditing; GMP documentation; change
control; annual product reviews; problem solving and root cause analysis; CAPA m
anagement; product quality complaints and failure investigations; SOP developmen
t; cGMP training; electronic document systems such as Master Control; consent de
cree remediation; FDA communication and negotiation; corrective action plan deve
lopment, tracking and closure. Strong leadership, mentoring and soft skills.
PROFESSIONAL EXPERIENCE
Amerigen Pharmaceuticals, Inc., East Brunswick, NJ 5/2009-
Present
Technical Consultant
Technical consultant for multinational pharmaceutical company with manufacturing
facilities in China. Provided support for the Quality organization by developin
g procedures and validation protocols, conducting supplier audits, training the
microbiology staff in technical matters such as microbiology test methods, ident
ification of microorganisms, environmental monitoring program, cleaning validati
on, equipment selection and qualification, investigations and corrective actions
, laboratory design, etc. Contract was completed.
Automation and Validation Solutions, Blue Bell, PA 5/2008-9/
2008
Managing Consultant on site at Merck
Project Manager to manage qualification of numerous controlled temperature unit
and mentor bio-sterile validation department head and organization in process va
lidation, quality systems and cGMP concepts; tracked and reported site project p
rogresso executives, coordinated progress toward goals, worked with the client t
o assure goals were met on a timely basis, provided staffing recommendations, an
d managed staff. Contract was completed.
Strides, Inc., Somerset, NJ 11/2005-12/2007
Director, Quality Assurance
Site head of Quality Assurance for this start-up US subsidiary of Indian based S
trides Arcolab. Provided the technical expertise, Quality Assurance leadership
and GMP Quality System know-how for the company's transition from a nutritional
product base to a generic drug product base. Directed and mentored a team consi
sting of one Assistant Director, three managers, three line inspectors, and vari
ous independent contractors in management of Quality Operations, Quality Systems
, Product Release, manufacturing and laboratory compliance, FDA inspections, cor
respondence and remedial actions. The company developed financial issues and wa
s sold.