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 to lead CQV activities for pharmaceutical utilities and facilities. You will develop and review CQV protocols (DQ/IQ/OQ/PQ) and document qualification tests ensuring GMP and regulatory compliance.

You will collaborate with engineering, QA, and operations, resolve technical issues during commissioning, and support audits and staff training on qualified systems and procedures.

Qualifications

• 3+ years in CQV for pharmaceutical utilities & facilities
• Strong understanding of GMP, validation processes, and regulatory requirements
• Hands-on experience with commissioning and qualification documentation and execution

Responsibilities

• Lead and execute CQV activities for utilities and facilities (HVAC, water systems, steam, compressed air)
• 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 guidelines
• Collaborate with engineering, QA, and operations 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 for pharma utilities

GMP & regulatory knowledge

HVAC & utility systems

Documentation & audits

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in Pharmacy or related technical field

Tools

DQ/IQ/OQ/PQ protocols

Job description

Jora Malaysia will close on 16th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

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