Project Manager Plant

Taylor Wu

Personal:

Sex: Male

Citizenship: Chinese/Tianjin

Self-Summary:

. Good knowledge of pharmaceutical industry and project management

. Expertise in GMP's project planning and implementation

. Possess good people management, communication and negotiation skills

. Has the clear sense in developing the business in China; also has the

strong and unique experience and skill in managing local people and

communicating with the local customers. Be very confident on his

ability, and wishes to bring his expertise into full play in China.

. Rich experience of GMP implementation of CFDA?FDA?EU and ICH etc..

. Rich experience of pharmaceutical industry Operations and Quality

management.

. Rich experience of validation execution for pharmaceutical industry.

. Rich experience of EHS for pharmaceutical industry.

. Overall competency:

< Strong project management skills

< Good knowledge of problem solvent and logical analysis

< Strong understanding and hands on experience of LEAN manufacturing

< Energetic, confident, highly motivated and willing to take great

challenge

< Build up infrastructure and develop talent pipeline. Encourage and

coach team members to exceed potentials.

< Strong global experience.

< Effective communication and presentation skill both verbally and in

written.

< Practical liaison experiences between user and project team

. Working Language: English and Chinese

Contact Information:

Mobile: 86-135********

Email: *********@*******.***.

Education and Training:

ShenYang Pharmaceutical University, majored in chemical engineering,

Bachelor obtained.

Tianjin University, industry enterprise management training

Nankai University, EMBA training

Qualifications:

1996's Pharmacist

2000's ISO14001 internal auditor

2001's Senior Engineer

Working Experience and Major Achievement:

1. Sep. 2011---Present Validation/GMP Consulting for

TianYuan bio-pharma

( a Novartis company)

. Facility system validation (HVAC/PS/PW/WFI).

. Process equipment validation.

. Cleaning validation.

. Cold chain validation.

. Computer system validation.

. Risk assessment.

. Change control/CAPA.

2. Jan. 2005 --- Present Beecham pharmaceutical technology

develop company

Tianjin, China. Director of OPS and

regulations Consultant

Working Experience and Achievement:

. Quality system audit of bio/pharmaceuticals product supply

chain.

. Validation service.

. SFDA/FDA/EU GMP project consultant.

. GMP related facility build project management.

. Facility, Process and Cleaning validation implement.

. EHS system set up and HAZOP project execution.

. Tolling manufacture sourcing and management.

. Quality System setup project consultant of pharmaceutical

industry.

?.Mar. 2000- Dec. 2004, TSK&F, a leading JV pharmaceutical company in

China

Tianjin, China. ( JV

of GSK )

Operation System

Project Manager

Working Experience: Draft project masterplan in terms of plant, process and

manufacturing layout etc., collect and consolidate client's requirements;

coordinate and track the execution of masterplan,validation plan and scale

up plan; GMP project implement supervision; draft project handover and

acceptance documents, liaison between project team and other related;

coordinate for the shutdown project schedule, handover and overall

commissioning .Technical transfer and other minor CIP projects implement

of Operations.

Achievements: During Nov. 2001 - Dec.2004, completion of upgrade and

expansion projects for the existing facilities and process equipment with a

total investment of $11 millions.

During Mar. 2000 - Oct. 2001, completion of a project for New Contac

product including construction of a new manufacturing plant and

installation of facilities and process equipment with a total investment of

$20 millions. Leading the other minor project: HVAC system updated project

it's cost $300,000.

?.Sep. 1996- Mar. 2000, TSK&F, a leading JV pharmaceutical company in

China

Tianjin, China. ( JV

of SB )

Operation System EHS

manager

Working Experience: Manage departmental daily operation including

Pharmaceutical plant EHS & GMP compliance, waste water treatment system

operation & draft and revise SOP (Standard Operation Procedure). Set up EHS

policy and Standard of TSK&F. Departmental. Opex./ Capex. management.

Achievement: During Mar. - Dec. 1999, completion of upgrade project for the

existing waste water treatment system with a total investment of RMB 2.4

million. The capacity of waste water treatment was increased from 150T/day

to 350T/day which meeting the National Exhaust Standard Grade II.

Environmental maintenance and management for GMP plant, draft and revise

SOP.6-APA plant decontamination project, facility destroy project and

underground water measurement project implement. Set up EHS management

system.

Completed 6APA plant decontamination project, it's cost $750,000.

?.Feb. 1990-Sep. 1996, TSK&F, a leading JV pharmaceutical company in

China

Tianjin, China. ( JV

of SB )

Operation Manager of

Pharm. Plant

Working Experience: Manage the daily operation of production system

including GMP compliance, production planning, process management &

staffing. Departmental Opex./ Capex. Management. Simply Better policy, lean

and CI tools training and project coordinator.

Achievement: involve in the preparation of design and construction and

complete commissioning all process equipment and utilities of Pharm. plant.

Manage the staff and materials during the pilot run to make sure that the

plant could be run smoothly and make a record that pilot run one-time

success. Since the regular operation of plant, manage the daily operation

of production department and improve the original design for process and

services to make the production capacity 20% higher than before. At the

same time, based on the requirements from foreign clients, improve

products' quality standards to facilitate the successful completion of

product export.

?. Jul. 1986-Jan. 1990, TSK&F, a leading JV pharmaceutical company in

China

Tianjin, China. ( JV of

SK&B )

Laboratory Senior Analyst

Working Experience: Be responsible for the establishment of corporate

laboratory and establish, evaluate and validate the test method for new

products.

Achievement: involve in the establishment of the corporate new laboratory,

establish and validate the test method for new products. Translate

documentation about propaganda and test method for new products. Be

responsible for the sample analysis of stabilizing test. Involve in the

product test work during 1986-1990.

Contact this candidate