Kerja Sepenuh Masa, Quality Assurance Engineer di Coalesce Management Consulting - Maukerja

We are looking for a Quality Assurance professional to support deviation management activities within a GMP-regulated manufacturing environment. This role will be responsible for reviewing, investigating, and managing quality deviations, ensuring proper root cause analysis, CAPA implementation, and timely closure in compliance with internal procedures and regulatory requirements.

Key Responsibilitie

• sManage the full deviation lifecycle, including initiation, investigation, review, approval, and closure
• .Lead or support root cause analysis and ensure proper documentation of investigation findings
• .Work with cross-functional teams to assess quality impact and close deviations on time
• .Support CAPA development, implementation, and effectiveness checks
• .Review deviation reports to ensure GMP compliance, accuracy, and completeness
• .Identify recurring deviation trends and support continuous improvement initiatives
• .Participate in audits and inspections related to deviation management when required

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Preferred Skil

• lsExperience supporting regulatory inspections or customer audit
• s.Experience in sterile manufacturing, biologics, fill-finish, or pharmaceutical production environments would be an advanta