Commissioning/Qualification/Validation Consultant

EFOR; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

EFOR is seeking an experienced Qualification & Validation Pharmacist in Singapore to qualify equipment, validate processes, and manage automation qualification efforts. The role involves coordinating with departments, leading analysis meetings, presenting protocols, and drafting quality documents.

The candidate should have 3+ years in pharmaceutical qualification/validation, fluent English, and management experience is a plus.

Qualifications

• At least 3 years' experience in qualification/validation within a pharmaceutical manufacturing environment.
• Fluent in written and spoken English.
• Experience in management is an advantage.

Responsibilities

• Qualify production equipment and utilities at clients’ sites (e.g., autoclaves, tanks, etc.).
• Validate production and cleaning processes and validate/qualify information systems and automation.
• Plan qualification and validation activities in coordination with relevant departments.
• Lead result analysis and problem-solving meetings.
• Present protocols and prepare reports.
• Conduct GAP analyses and periodic reviews of equipment and systems.
• Contribute to tracking and updating validation and qualification master plans and indicators.
• Draft, review, and approve quality documents.
• Propose improvements to qualification processes and implement continuous improvement tools.
• Manage external service providers supporting the qualification/validation team.
• Provide quality expertise in drafting User Requirement Specifications for new facilities and equipment.
• Verify User Requirement Specifications.
• Act as a reference point within your area of responsibility.
• Participate in onboarding and training of new employees.

Skills

Qualification & Validation

GxP knowledge

Project leadership

English proficiency

Job description

As part of our company's growth, we are seeking an experienced Qualification & Validation Pharmacist to join our team. You will be responsible for:

• Qualifying production equipment and utilities at our clients’ sites (e.g. autoclaves, tanks, etc.)
• Validating production and cleaning processes
• Validating and qualifying information systems and automation systems
• Planning qualification and validation activities in coordination with relevant departments
• Leading result analysis and problem-solving meetings
• Presenting protocols and preparing reports
• Conducting GAP analyses and periodic reviews of equipment and systems
• Actively contributing to the tracking and updating of validation and qualification master plans and indicators
• Drafting, reviewing, and approving quality documents
• Proactively proposing improvements to qualification processes and implementing continuous improvement tools
• Managing external service providers supporting the qualification/validation team
• Providing quality expertise in drafting User Requirement Specifications for new facilities and equipment
• Verifying User Requirement Specifications
• Acting as a reference point within your area of responsibility
• Participating in the onboarding and training of new employees

Please note that this list is not exhaustive and may evolve depending on the needs of the role.

Profile Sought:

• At least 3 years' experience in qualification/validation within a pharmaceutical manufacturing environment
• Fluent in written and spoken English
• Experience in management is an advantage