Manager Control
Resume:
LICHI WAN
Milpitas,CA. ***** ( 408-***-**** ( *********@*******.*** (
www.linkedin.com/in/lichiwan
With 15 plus years experience in GMP Pharmaceutical environments. Expertise
in FDA and ICH guidance and regulations. Deep Background in QA document
control, clinical supplier labeling, stability study management, raw
material control, drug product in-process inspection, finished product
release and analytical method/validation report review approval process.
Experienced in cleaning validation and verification.
. Helped establish QA department. Successfully helped company pass FDA,
DEA and partner's inspections and supported company's 100+ submissions.
. Reviewed CMO master and executed batch record.
. Performed OOS investigation and Corrective Action/Preventive Action
(CAPA) implementation.
. Software: TrackWise for investigation and SOP training, SAP for QA
sampling, material disposition and retest/expiration date assignment,
Sapphire LIMS for stability studies, acted as system administrator,
eTIME for non-exempt employee working hour management.
PROFESSIONAL EXPERIENCE
IMPAX LABORATORIES, INC., Hayward, CA
1996-2013
Senior QA Manager (1/2007 - 6/2013)
QA Manager (8/2004 - 1/2007)
Managed QA department, including QA documentation control, stability
control, raw material control, specification creation and approval,
analytical data review and approval, production floor support and QA
related deviation investigation and CAPA implementation. Managed
department's routine activities during absence of director. Provided GMP
training to 10 group members.
. QA Document Control: Oversaw QA documentation control system including
master and executed document distribution, filling and storage.
. Stability Study: Supervised all stability study related activities:
stability study protocol reviewing and approval; study initiation,
monitoring; test result reviewing and approval; chamber charts, PM and
calibration certificates reviewing.
. Raw Material Control: Managed raw material warehouse; supervised QA
related activities: material sampling, creation of the test
specifications, lab data approval and material disposition, material
risk assessment, material qualification system, vendor approval process.
. Analytical Laboratory Support: Approved analytical methods, validation
protocols and reports; method transfer protocols and reports. Approved
raw material and drug product specifications and release test results.
. Production Support: Created cleaning validation (CV) protocols, reviewed
CV results and released equipment for production; took and inspected in-
process samples, reviewed in-process samples test results; approved
master and executed batch records; and released drug products for BE or
clinical studies. Reviewed CMO production batch records.
. Investigation and CAPA: Performed investigation for raw material and
drug product OOS results and other QA related incidents. Implemented
CAPAs. Acted as key person for internal audit response and CAPA
implementation.
. Controlled Substances: Issued and approved DEA 222 forms; supervised
controlled substances and precursor substances receiving, shipping,
transferring and disposal.
Milpitas,CA. 95035 ( 408-***-**** ( *********@*******.*** (
www.linkedin.com/in/lichiwan ( Page 2 of 2
IMPAX LABORATORY EXPERIENCE (continued)
QA Supervisor (11/2002 - 8/2004)
Team Leader (2/2001 - 11/2002)
Supervised QA documentation control, stability control, raw material
control, specification creation,
analytical data review, production floor support and related deviation
investigation and CAPA implementation. Supervised department's routine
activities during absence of director.
. QA Document Control: Oversaw QA documentation control system including
master and executed document distribution, filling and storage.
. Stability Study: Supervised all stability study related activities,
including stability study protocol reviewing, study initiation,
monitoring, test result reviewing, chamber charts, PM and calibration
certificates reviewing.
. Raw Material Control: Managed raw material warehouse, supervised QA
related activities: material sampling, lab data approval and material
disposition, material risk assessment, material qualification system,
vendor approval process.
. Analytical Laboratory Support: Reviewed analytical methods, validation
protocols and reports; method transfer protocols and reports, created or
reviewed raw material and drug product specifications and release test
results.
. Production Support: Created cleaning validation (CV) protocols, took CV
samples, reviewed CV results and released equipment for production; took
in-process samples and reviewed test results; approved master and
executed batch records; Reviewed CMO production batch records.
QA Associate (4/1998 - 2/2001)
Helped establish QA department. Distributed QA approved documents to other
departments; took raw material samples and release raw materials for
production; took cleaning validation/verification samples; reviewed lab
test results and released equipment for production; took in-process and
finished product samples for production; created stability study protocols,
initiated the studies and pulled samples. Oversaw raw material inventory in
warehouse.
Analytical Chemist (3/1996 - 4/1998)
Performed raw material and drug product release tests, including
dissolution, assay, impurities and other tests. Managed lab samples login
and inventory and oversaw raw material inventory in warehouse.
EDUCATION PROFESSIONAL DEVELOPMENT
Bachelor of Science in Biology, Jiangxi University, Nanchang, Jiangxi
Province, China
Technical Classes: Deviation Reporting, Root Cause Analysis and Failure
Investigation, ASQ/RAPS Documenting Key Quality and Regulatory Processes,
New Perspective on Cleaning Validation: Science and Risk Based Approaches.
Dangerous Documentations: Avoiding Landmines in Your FDA Records and
Emails, GMP Essentials.
Leadership Classes: Leadship IQ, Core Communication Skills for Managers.
Understanding Pharmaceutical Quality by Design.
Contact this candidate