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Senior Validation and Qualification consultant

Keywords / Skills : Senior Validation and Qualification consultant

4 - 7 years
Posted: 2019-06-23

Industry
Recruitment/Staffing/RPO
Function
IT
Role
Software Engineer/Programmer
Posted On
23rd Jun 2019
Job Ref code
BBBH6793_1561012366
Job Description
Job Description :

My client are looking for 2 senior individuals to provide overall leadership, management and execution of the technical aspects of equipment qualification which encompass project
management, qualification related documents preparation and review, related
procedures preparation and review, execution of qualification/validation activities
and problem-solving etc.

Key Responsibilities:

Provide overall management and leadership for equipment qualification activities,
which includes all ancillary systems such as computer system validation,
commissioning and site preparation

Collaborate with client to ensure all tasks are delivered based on client's quality
systems and operational systems

Identify, develop, track performance metrics for the project team to effectively
monitor project status and to ensure effective collaboration with client

Write and review qualification related documents which include change control,
user requirement specification, functional specification, installation qualification
protocol and report, operational qualification protocol and report, performance
qualification protocol and report, traceability matrix, operating SOP, calibration and
maintenance SOP etc

Lead in troubleshooting and problem solving during the course of qualification and drive timely completion of project based on stipulated project timeline

Regular and timely report/update to the Senior Consultant/Director on the
progress of the project

Provide training to staff in terms of GMP training, regulatory update, equipment
related training etc

Competencies:

Bachelor Degree in Chemistry, Biochemistry, Biotechnology or equivalent
At least 4 years of experience in Pharmaceutical, Biopharmaceutical or related
manufacturing environment.
Demonstrate strong ability to lead and drive project to completion independently.
Demonstrate strong technical experience e.g. in the area equipment qualification,
deviation management and investigation
Demonstrate strong project management capability.

Job Requirement:
Leadership and Project Management Skills

Technical Skills

Good technical writing ability in English and computer literacy
Has advance knowledge and understanding in terms of regulatory standards
requirements e.g. USP, EP, 21CFR, ICH etc.
Substantial knowledge in computer systems validation and requirements
Substantial equipment qualification knowledge

Problem solving
Solves problems and implements corrective actions using six sigma tools
Presents in a timely manner major issues to the overall project lead and senior consultant/director
Leading taskforce to solve major or critical technical issues/problems
Demonstrate ability to detect issues and strategize next course of actions effectively

Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).



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