No deviation

Senior QA Executive (Contract)

No deviation  •  Singapore, SG (Onsite)  •  3 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 a Senior / QA GMP Executive to provide QA oversight and ensure compliance with cGMP requirements across manufacturing operations. This role supports batch usage decisions, deviation management, change control, and overall quality compliance within a regulated pharmaceutical manufacturing environment.

This is a critical quality function that partners closely with Manufacturing, Engineering, and Regulatory teams to maintain high standards of GMP compliance and inspection readiness.

Key Responsibilities

  • Provide QA oversight in day-to-day manufacturing operations to ensure cGMP compliance.
  • Conduct routine QA checks (line clearance, housekeeping, checklist reviews, SOP compliance, process confirmation).
  • Authorise campaign changeovers and participate in facility walkdowns.
  • Support deviation investigations, CAPA implementation, and change control monitoring.
  • Authorise QA processes including Production Process Orders, Quality Tag Outs (QTO), equipment and room releases.
  • Review and approve - SOPs and checklists, Master Batch Records, Deviations and CAPAs, Change Controls, Quality Tag Out/In Documentation.
  • Review executed batch records (sterile buffers, intermediates, final bulk products).
  • Ensure accuracy, completeness, and timeliness of reviews.
  • Perform QA review and determine usage decisions for sterile buffers and intermediates.
  • Approve release status and move batches to restricted status where required.
  • Support site complaint investigations and perform risk assessments and gap analyses.
  • Conduct self-inspections and periodic quality reviews.

  • Support regulatory and corporate inspections.

  • Contribute to site KPI reporting (where appointed).

  • Act as Subject Matter Expert (Senior level), including SOP ownership and training of personnel.
  • Determine batch record closure and forward processing suitability.
  • Authorise QA release-related activities.
  • Assess compliance status and escalate non-compliance issues where necessary.
  • Implement practical quality process improvements.
  • Front corporate or regulatory inspections.

Required Qualifications

  • Bachelors degree in Science, Pharmacy, Engineering, or related discipline.
  • 3–5 years of pharmaceutical industry experience.
  • Strong understanding of GMP and regulatory standards.

  • Hands-on experience in pharmaceutical manufacturing processes.

  • Experience supporting regulatory inspections.
  • SAP knowledge preferred.

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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