CQV (Utilities & Facilities) Consultant

EFOR; Johor Bahru; On-site; MYR 120,000 - 180,000; Full time

Job summary

EFOR is seeking an experienced Qualification & Validation Pharmacist in Malaysia to lead CQV activities for utilities and facilities. You will develop and execute qualification protocols (DQ/IQ/OQ/PQ) and document tests and reports to ensure GMP compliance.

Collaborate with engineering, QA, and operations to support project delivery, review technical documents, and participate in risk assessments and change control. English fluency required.

Qualifications

• 3+ years CQV experience for pharmaceutical utilities & facilities.
• Understanding of GMP, validation processes, and regulatory requirements.
• Experience with commissioning and qualification documentation and execution.
• Excellent communication and interpersonal skills.
• Ability to work independently and in cross-functional teams.
• Strong analytical, troubleshooting, and problem-solving skills.
• English fluency; other languages are an advantage.

Responsibilities

• Lead and execute commissioning, qualification, and validation (CQV) activities for utilities and facilities (HVAC, water systems, steam, compressed air, etc.).
• Develop and review Qualification protocols (DQ, IQ, OQ, PQ) for utility and facility systems.
• Prepare, execute, and document qualification tests and reports for utilities and facilities.
• Ensure compliance with GMP, FDA, EMA, and relevant industry standards and guidelines.
• Collaborate closely with engineering, QA, and operations teams to support project delivery.
• Identify and resolve technical issues during commissioning and qualification.
• Review and approve technical documentation (URS, SOPs, design documents).
• Participate in risk assessments and change control processes as required.
• Provide technical expertise during audits and inspections.
• Support training of site staff on qualified systems and procedures.

Skills

CQV experience

GMP knowledge

Regulatory compliance

HVAC & utility systems

Documentation & QA collaboration

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:

• Lead and execute commissioning, qualification, and validation (CQV) activities for utilities and facilities (HVAC, water systems, steam, compressed air, etc.).
• Develop and review Qualification protocols (DQ, IQ, OQ, PQ) for utility and facility systems.
• Prepare, execute, and document qualification tests and reports for utilities and facilities.
• Ensure compliance with GMP, FDA, EMA, and relevant industry standards and guidelines.
• Collaborate closely with engineering, QA, and operations teams to support project delivery.
• Identify and resolve technical issues during commissioning and qualification.
• Review and approve technical documentation (URS, SOPs, design documents).
• Participate in risk assessments and change control processes as required.
• Provide technical expertise during audits and inspections.
• Support training of site staff on qualified systems and procedures.

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

Profile Sought:

• Proven experience (3+ years) in CQV for pharmaceutical utilities & facilities.
• In-depth understanding of GMP, validation processes, and regulatory requirements.
• Strong knowledge of utility systems (HVAC, clean/pure water, steam, compressed gases, waste systems).
• Hands-on experience with commissioning and qualification documentation and execution.
• Excellent communication and interpersonal skills.
• Ability to work both independently and in cross-functional teams.
• Strong analytical, troubleshooting, and problem-solving skills.
• English fluency (written and spoken); other languages are an advantage