CQV Documentation Lead – BioPharma (Hybrid/Remote)

About the role

PES International is seeking a CQV Documentation Lead to support its Life Sciences projects. The role involves preparing, reviewing and managing validation documentation for bio‑pharma facilities, working in a hybrid or remote environment.

Key responsibilities

• Develop and review CQV lifecycle documents such as URS, DQ summaries, IQ, OQ and PQ protocols and reports.
• Author validation protocols and reports in line with site procedures and regulatory expectations.
• Maintain proper document formatting, version control and traceability throughout the document lifecycle.
• Coordinate with CQV engineers, QA, project stakeholders and external vendors to gather and verify technical inputs.
• Support document revisions, approvals and close‑out activities to meet project timelines.
• Ensure documentation complies with GMP (EU/FDA), Annex 15, ASTM E2500 and site‑specific quality systems.
• Maintain audit‑ready documentation, track status and assist in timely delivery of validation deliverables.
• Contribute to risk assessments, traceability matrices and change‑control documentation.
• Occasionally travel to Malaysia as required.

Required profile

• Proven experience preparing CQV documentation for pharmaceutical or related life‑science projects.
• Strong understanding of GMP regulations, Annex 15 and ASTM E2500 standards.
• Ability to work collaboratively with cross‑functional teams and external partners.
• Excellent attention to detail and commitment to audit‑ready documentation.

Required skills

• CQV documentation
• GMP (EU/FDA) compliance
• Annex 15
• ASTM E2500
• Risk assessment
• Traceability matrix
• Change‑control documentation