Job Overview

This role’s focus is on the provision of technical guidance, planning, coordinating and resourcing validation projects on-site. He/She ensures the qualification and validation of equipment, facilities, utilities, and processes are carried out in accordance with cGMP and ISO 17025 guidelines. This role is also expected to lead projects with various stakeholders and will be responsible for a small team to deliver results and projects for the site.

Job Description

DUTIES AND RESPONSIBILITIES

1. Manage and lead parts, if not all of the lifecycle for validation projects, including but not limited to; delivering on time, to specification and ensuring the delivery of a quality validation project.
2. Responsible for leading, guiding and preparing the installation of and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate, internal company standards and current industry standards
3. Lead, plan, communicate, coordinate and execute simple and complex projects within Charles River Singapore and other sites by using planning tools like Gantt chart and other Project Management Tools.
4. Write or assist in writing of SOPs for Equipment and Facility related Validation Projects.
5. Participate in validation project meetings, workshops, training of staff and production of related documentation.
6. Lead evaluation of Systems from different vendors for submission of Capital budgetary papers, and to recommend the most appropriate systems, based on User Requirement Specification, and/or other specifications as required from site management and project.
7. Provide progress reports on Projects and communicate with relevant stakeholders.
8. Manage direct relationships with key project stakeholders.
9. Lead and self-initiate projects to improve efficiency and productivity of the processes.
10. Represent the Department in client audits as required as a SME.
11. Independently perform investigations as required and effective apply 6M or Ishikawa fishbone diagram, or any other applicable tools for Root Cause Analysis and evaluate practicality of actions to be applied.
12. Able to communicate investigations succinctly and accurately.  
13. Monitor and trend cost expenditure over a defined period for monitoring of cost effectiveness for the department.
14. Maintains proper records and documentation of activities that are compliant with good documentation practices, continuous compliance ISO/IEC 17025, cGMP, PIC/S, ISPE Guidelines, WHO Technical Reports, Company global SOPs and other data integrity principles for all activities.
15. To work closely with all departments to ensure the operation of a validated environment according to existing QMS and/or other regulatory requirements.
16. Performs all functions as tasked with high degree of accuracy and strict adherence to company’s quality requirements.
17. Reviews aspects/areas for improvement within your own duties/responsibilities and make recommendations to your line manager for your own or team improvements.
18. Adheres to Company Policies and Procedures.
19. Undertakes any other duty or responsibility, at the request of your manager that may be required within reason within the remit of your role.

General requirements

• Maintains confidentiality of all Client information according to internal SOPs, Quality Service Agreements, and regulatory requirements.
• Actively seeks improvement within area of responsibility and takes necessary action to implement such improvements.
• Adheres to Company Policies and Procedures, including Code of Ethics and to Health and Safety requirements.
• Performs all other related duties as assigned.

Qualification

1. Education: Possesses at minimum, a degree in Engineering, Biomedical Sciences or any related field.
2. Experience:
   1. Minimum ≥ 5 years of relevant experience working in an ISO17025 / GMP environment is preferred.  
   2. Understanding of IT is expected, related to installation of software, interface of hardware and software and basic administrative controls of Windows (Such as adding user groups) is preferred.
   3. Understand concepts and rationale, and execute System Commissioning, Qualification and Validation for systems as per requirements stated in ISPE GAMP 5 and USP <1058> document is required.
3. An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
4. Others:
   1. Effective communication and supervisory skills
   2. Ability to organize and prioritize work to meet deadlines
   3. Ability to read, write, speak and understand English