VLADIMIR KHAYKIS

**-** ******* ******, **** Lawn, NJ 07410

718-***-**** (c) 201-***-**** (h)

acpb8t@r.postjobfree.com

PROJECT MANAGEMENT AND COMPLIANCE EXPERT

Decisive, results-focused professional experienced in supervising people

and simultaneous management of multiple concurrent projects within schedule

and management expectations. Experienced in Technical Writing of various

types of documents. In depth knowledge of cGxP, USP, DEA, EurPh, WHO and

FDA regulations and guidelines. Extensive background in development and

validation of analytical methods.

PROFESSIONAL PROFILE

Novartis Pharmaceuticals, Suffern NY (contract)

June 2013-December 2014

Technical Writer II, Manufacturing and Packaging Technical Operations

Support

Wrote SOPs and technical documents for manufacturing and packaging

operations.

Supported documents lifecycle from inception (new document or revision)

through review and approval. Prepared training materials and knowledge

assessments. Worked with training department in assessing documents risk

level, training requirements and curricula changes.

Wrote protocols and reports for manufacturing investigations and process

changes.

Pfizer Biotechnology/Vaccines, Pearl River, NY

January 2007-July 2012

QC Compliance Manager, QC Compliance and Support

Managed projects and activities directed to increase and maintain cGMP

compliance of Quality Control operations. Managed support tasks for QC

operations and performed Quality Assurance function for QC. Monitored QC

activities for adherence to cGMP compliance and Quality Systems

requirements.

. Managed and led projects for purchasing, installation and qualification

of new computerized testing instruments and equipment, that numbered over

100 units that were put into cGxP operation or re-qualified. Projects

involved cross-functional teams from various Pfizer departments as well

as outside vendors and contractors. Most of the large scale projects

required use of formal project management tools such as Gannt charts,

identifying critical points and paths, resource allocation and interim

reports.

. Initiated and led to closure more than 100 change controls per year. For

last four years all change controls were closed in time or ahead of time.

Change control process was completed by running projects of different

scale using both formal project management tools and informal approach.

. Supervised laboratory computers administration activities in compliance

with 21 CFR 11 requirements.

. Key member of QC Compendial Review Committee that reviewed and discussed

impact of PF publications and revisions in EurPh and JP on QC operations,

which always resulted in a timely adjustment of QC operations to proposed

changes.

. Consistently achieved no major or serious observations or 483 letters in

QC during audits performed by Regulatory bodies and Ministries of Health

from various countries.

. Facilitated transfer of forensic testing for resolution of customer

complaints to Vaccines QC and participated in complaint samples testing

and reports preparation.

VLADIMIR KHAYKIS

Wyeth Vaccines, Pearl River, NY

September 2001-January 2007

Manager Global Reference Standards group

Initiated, developed and managed centralized system in Wyeth Vaccines for

acquisition, inventory control, storage, qualification and distribution of

reference standards and controlled substances. Initiated in response to

Consent Decree, this commitment was closed in time with commendation from

FDA reviewers.

. Managed inventory of more than 200 reference standards and multiple lots

of antibodies.

. Managed projects for implementation of new lots and new types of

standards for compliance and regulatory impact. Conducted discussions

with site Regulatory Review Committee and with Regulatory Authorities

representatives from different countries.

. Initiated and managed projects for production, qualification and

implementation of new lots of standards and antibodies to replace

exhausted and expired inventory.

. Supplied Wyeth Vaccines worldwide users, affiliates and regulatory bodies

(more than 150 shipments per year) with reference standards and

antibodies.

. Implemented computerized inventory and ordering system which reduced

processing time by 50 % and allowed overseas customers to check available

inventory and place orders 24 hours a day.

ESI-Lederle, Wyeth Generics, Pearl River, NY

March 1995-September 2001

Senior Scientist, R&D Analytical Development Group

Developed and validated new analytical methods and testing procedures for

generic Solid Dosage Forms and injectables supporting ANDA submissions.

. Provided analytical support for generic drugs formulation and stability

groups, utilizing various types of analytical techniques including

instrumental chemical and physical testing methods (GC, HPLC,

dissolution, FTIR, UV/Vis, DSC/TGA, particle size, KF, etc.).

. Wrote SOP's, Standard Analytical Procedures, Monographs, methods transfer

documents.

COMPUTER SKILLS

Experienced in all components of Microsoft Office suite including MS

Project. Working knowledge of LW LIMS, SAP, TrackWise.

EDUCATION

M.S. Physical Chemistry, Urals Polytechnical Institute, Sverdlovsk, USSR

Leningrad State University, Leningrad, USSR

Selected Post-graduate level courses in Analytical Chemistry.

RAC (US) certification (2013).

Regulatory Affairs Professional Society, Dual Certificate "Medical Devices

and Pharmaceuticals"

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