Senior QA Specialist
Date Posted: March 13, 2026
Job Description
Key Responsibilities
Quality Oversight & Compliance: Direct site quality systems to ensure ongoing alignment with GMP and regulatory requirements. Provide real-time QA guidance during operational activities to keep processes audit-ready.
Deviation & CAPA Management: Lead deviation investigations, including deep-dive root cause analysis. Coordinate the implementation of effective corrective and preventive actions (CAPAs) to prevent recurrence.
Document Control & SOP Authorship: Lead the authoring, structuring, and revision of SOPs and controlled documents. Ensure all documentation remains clear, compliant, and synchronized with site procedures.
Change Control Management: Manage change control activities by performing thorough impact assessments. Ensure all modifications to processes or equipment remain documented within the quality management system.
Continuous Improvement: Drive initiatives to optimize site quality processes and documentation practices, reducing waste and increasing compliance reliability.
Cross-Functional Collaboration: Partner with Operations, Engineering, and Technical teams to embed quality standards into daily manufacturing and site support activities.
Inspection Readiness: Execute inspection readiness strategies. Maintain quality documentation to ensure the site meets the high expectations of regulatory bodies during audits.
Required Qualifications and Skills
Professional Experience: Minimum 5 years of Quality Assurance experience specifically within a pharmaceutical or API manufacturing environment.
Regulatory Knowledge: Deep understanding of global GMP standards and the ability to interpret regulatory expectations for site-wide application.
Technical Writing: Exceptional skills in authoring and structuring technical SOPs and complex investigation reports.
Problem Solving: Proven expertise in root cause analysis methodologies (e.g., Fishbone, 5 Whys) and CAPA management.
Soft Skills: Strong ability to influence cross-functional teams and advocate for quality-first mindsets in a fast-paced production environment.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E