Scientific writer/Director

1. IGNACE VALLEJO
718-946-0556 917-359-3028
525 Neptune Avenue, Brooklyn, New York 11224
ianvallejo@hotmail.com ianvallejo7@gmail.com
www.linkedin.com/in/ignacevallejo/
I am applying for the position of Sr Medical Writer. My last projects as
an independent contractor were with VIRBAC USA, LONZA and
NOVARTIS. I conducted Product Investigations from Inoculations of
Media to Manufacturing projects which included from line clearance
issues to inclusions of foreign material. Also, Inspection of all product
packaging to determine a non-negative product impact. I conducted both
internal and external audits. I conducted Monthly GMP training for all
new Employees in the plant regardless of their position. I bring to the
position my knowledge, experience, professionalism, communicative
skills, interpersonal skills, work ethics and high quality work. I delivered
100%, on time and before due date all reviews and re- leases of batch
records. I incorporated their review and release as well as protocol for R
& D. I initiated changes to many of our S.O.P.’s to make them more
efficient and to assure that we were always in compliance with all
GMP’s. I conducted Monthly meetings with senior staff advising them
of existing project progress and initiating recommendations to improve
existing procedures and quality audits. The audit plan and agenda need
to be approved by the CRO Quality Department. Once approved, I will
arrive to the audit site. The CRO will provide me with an overview of
their company operations. I will then obtain from the company their
Master Control Log Book and the SOP’s required for the particular
study being audited, as well as the patient studies. Once I meet with the
project mgr, I request to receive all training records (related to the study)
for both the project manager and assistant project manager. I will also
randomly choose 10 employees and request to receive their training
records related to the study. I have 10 years of experience in GCP’s and
conducting audits, from CRO’s to Vendor’s. My most common audit

2. observation is that CRO’s tend not to follow their own SOP’s. I also
have conducted multiple audits in France as well as training Doctors,
nurses and CRAs in Moscow (Russia). This helped to expedite the
approval of the drug by the applicable Governmental Agencies. My role
in the QA dept is to bring my experience and expertise, which hopefully
will enhance and make more efficient the group performance. Also, to
become a productive participant and contributor to the team effort, to
enhance the group ability to work as cohesive team. Contributing to each
other’s efforts and objectives. And, to encourage a constant flow of
communication in order to assure that everyone is updated as to the team
goals and objectives of both short and long term projects. Ignace brings
15 years of experience in the Biotech/Pharmaceutical Industry in Quality
Assurance and Quality Control. He has extensive knowledge of all of the
applicable regulatory requirements.
At Hospira (Division of Abbott Laboratories) Ignace’s responsibilities
included:
• Solutions to the exception reports through meetings, 3rd party
teleconferencing and investigations.
Over two dozen products were involved. Approximately one dozen
products were manufactured for 3rd parties. All products had
acceptable results and were released.
• Delivered investigations and exception reports on time by
executing each investigation, as follows:
1. Fishbone: Personnel, Methods, Equipment, Material, Historical,
Miscellaneous.
2. Risk Assessment: Scope, Objective, Assumption. Acceptance
Criteria, Risk assessment, Results/Recommendation.
3. Root Cause: Machine, Material, Environment, Personnel, and
Method/De- sign.
4. Exception Report: Description (Event), Impact Assessment
(Final Impact Assessment, Investigation Detail, Time of Events),
Historical Check/Investigation Analysis (Historical Review,

3. Investigation Analysis (personnel), Equipment/Instrument
Assessment, Material, Process/methods (Process Overview),
Investigation Findings (Scope, Root Cause Classification, Root
cause description, Correction Type, Recommended Actions,
Summary and conclusions.
The results of all these investigations produced an exceptional
improvement in all processes, thereby reducing subsequent
exceptions by over 86.25% with no product impact.
Ian has worked with Pfizer, Bristol Myers Squibb and recently
with Laureate Pharma Inc. as a Senior QA Compliance
Specialist. His responsibilities included everything from review of
Upstream/Downstream/stability studies, filling batch records,
performing internal and external audits, sales to clients, while
adhering to cGMP and 21 CFR part 211 guidelines assuring that
CAPAs, Deviations, and Investigations were always in
compliance. Ian audited and monitored the compliance status of
company quality related operations and subcontractors.
Maintaining audit schedules and quality audits files for regulatory
agencies. Ian reviewed and approved internal and external
manufacturing records, batch records, protocols, and analytical
records. Monitoring and reviewing and /or approving CAPAs,
Deviations, amendments, investigations, out of specifications
results and nonconformance.
While at Pfizer, as a QC associate, he had the responsibility to
release Viagra, Zoloft, Zyrtec, Diflucan, and Trovan under the
guidelines and regulations of USP and EP. He identified
deficiencies and provided solutions and improvements as well as
preventive actions in order to be compliant in all regulatory
operating areas as defined in cGMP, GLP, 21 CFR & CAPAs.

4. In addition, working at Bristol Myers Squibb , Ignace had the
responsibility to release hard tablets such Sustiva, Cumadin, and
Morphine sulfate according to regulations and guide lines of USP and
EP.
Ian is a Certified cGMP Quality Auditor and earned his masters degree
in Biology from Adelphi University and his B.A degree in Biology from
the University of Rochester.
The above is a representation of my proactive and multitask ability that
any company hiring me can take advantage of immediately.
Sincerely .
Ian Vallejo