CQV Quality Systems Lead — GMP & Compliance

MSD Malaysia; Boxmeer; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary based on knowledge

Annual bonus based on performance

35.5 days paid leave

Travel allowance and pension

On-site restaurant and parking

Job summary

MSD Animal Health in Boxmeer is seeking a Specialist Quality System & Compliance - CQV to lead commissioning, qualification and validation for a new state-of-the-art facility. You will act as the Quality representative across CQV activities ensuring facilities, utilities and systems meet global quality standards and data integrity requirements.

You will collaborate with Engineering, Automation and Operations to embed quality, support regulatory inspections, and drive continuous improvement in

Qualifications

• Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Life Sciences or a related discipline.
• At least 5-8 years of experience in Quality Assurance, Validation, Engineering Quality or Commissioning, Qualification & Validation within GMP-regulated pharma/biotech.
• Proven experience with qualification and validation of facilities, utilities, equipment and computerized systems.

Responsibilities

• Act as QA representative for CQV across facilities, utilities, equipment and computerized systems.
• Review and approve validation strategies, qualification plans and CQV deliverables (URS, DQ, IQ, OQ, PQ).
• Ensure compliance with EU GMP, FDA cGMP, Annex 11/15, CSV, data integrity and company standards.
• Partner with Engineering, Automation and Operations to embed quality through the system lifecycle.
• Participate in risk assessments, design reviews, FATs/SATs and validation activities.

Skills

cGMP Regulations

Equipment Qualification

GMP Compliance

Manufacturing

Operational Qualification

Quality Management Systems

Root Cause Analysis

Validation Activities

Education

Bachelor's or Master's degree in Engineering or related

Job description

MSD Animal Health in Boxmeer is seeking a Specialist Quality System & Compliance - CQV to lead commissioning, qualification and validation for a new state-of-the-art facility. You will act as the Quality representative across CQV activities ensuring facilities, utilities and systems meet global quality standards and data integrity requirements.

You will collaborate with Engineering, Automation and Operations to embed quality, support regulatory inspections, and drive continuous improvement in