No deviation

CQ Manager - Drug Product

No deviation  •  Singapore, SG (Onsite)  •  4 months ago
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Job Description

About No deviation

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

We are seeking an experienced CQ Manager Drug Product
to manage commissioning and qualification of our sterile fillfinish facility. You will be responsible for ensuring that aseptic manufacturing systems, isolators, packaging equipment, lyophilizers, and cleanroom environments meet GMP, Annex 1, and regulatory requirements. In this role, you will lead cross-functional teams, oversee protocol execution, troubleshoot technical challenges during startup, and maintain audit-ready documentation. Your work will directly support the manufacture of safe, high-quality drug products that reach patients worldwide.

Key Responsibilities

  • Lead CQV activities for isolators, filling lines, lyophilizers, packaging and capping machines, compounding systems, and cleanrooms.
  • Execute protocols and documentation (FAT/SAT, URS, IQ/OQ/PQ, cleaning validation support).
  • Ensure equipment and processes meet GMP, Annex 1, and aseptic processing standards.
  • Collaborate with Aseptic Operations, Engineering, QA, MSAT, and vendors.
  • Resolve equipment issues during startup and ensure reliable batch execution.
  • Drive risk assessments, deviation investigations, and change control.
  • Support inspection readiness for regulatory agencies.

Required Qualifications

  • Degree in Engineering, Pharmaceutical Sciences, or related field.
  • 10+ years CQV experience in sterile fillfinish or aseptic manufacturing.
  • Familiarity with isolator technology, lyophilization, and aseptic processing is required.
  • Strong understanding of Annex 1 requirements.

Why join us?

  • Generous Leave Policy.
  • Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
  • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
  • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
  • Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

No deviation

About No deviation

Founded in 2007, No deviation is a trusted partner to pharmaceutical and biotech companies seeking smarter ways to deliver compliance. From engineering consultancy to CQV execution, regulatory compliance, and digital enablement, we support our clients across the entire project lifecycle in Asia, Europe.

We specialise in:

CQV (Commissioning, Qualification & Validation)

Lean, risk-based approaches aligned with GAMP 5, Annex 15, and ASTM E2500.

Quality, Compliance & Regulatory

Audit readiness, QMS remediation, documentation, and training.

Project Management & Technical Support

From operational readiness to vendor coordination.

Digital Enablement

Implementation of paperless validation (e.g. Kneat Gx), data integrity, and process digitalisation.

Specialised Training & Talent Support

Upskilling programs and resource placement to accelerate project success.

Our approach is rooted in patient safety, process understanding, regulatory compliance, and a constant drive for operational excellence in terms of safety, quality, delivery, and cost.

If you’re troubleshooting a deviation, planning a major CQV deployment, or scaling digital validation tools, we work side-by-side with your teams to deliver meaningful outcomes. Our methodology draws from ICHQ9 risk principles, with a hands-on framework: Understand - Observe - Define - Implement.

Want to learn more about paperless CQV, digital QMS, or project-ready resources? We’re happy to talk. Visit nodeviation.com to explore how we can support you.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Singapore, SG
Year Founded
2007
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