Quality Operation Manager
Reckitt
full-time
Posted on:
Location Type: Office
Location: ChaChoengsao • 🇹🇭 Thailand
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Identify and resolve quality problems from internal operations and external suppliers
- Collaborate with Production Manager to determine support needs from other teams
- Recommend and implement improvements to processes, procedures, and systems
- Assess change controls, protocols, and NCRs; recommend product release decisions
- Coordinate document control and assist with quality system training
- Maintain competency in GMP and operational quality standards
- Conduct impact assessments for all change controls affecting quality
- Participate in risk management for NPD, EPD, and change controls; define risks and actions
- Sign off on quality risk assessments and follow up on implementation actions
- Review and approve validation and qualification packages per VMP matrix
- Review master batch records and create sampling plans for in-process controls
- Ensure all products meet quality specifications and customer expectations
- Approve deviation reports and screen QIs per SOP guidelines
- Lead investigations for deviations and critical issues using root cause analysis tools
- Coordinate escalation processes for CEP-level issues
- Coach teams on deviation investigations and corrective actions
- Investigate customer complaints and ensure CAPA management through deviation processes
- Conduct trend analysis with cross-functional teams to monitor process control and raise improvement actions
- Keep risk management plans updated and revise as needed
- Ensure goods storage and distribution comply with GDP standards
Requirements
- Minimum 5 years in medical device or pharmaceutical industry
- Strong knowledge of GMP, ISO13485, ISO14971, and regulatory standards
- Knowledge or training in ISO/IEC 17025 (preferred)
- Expertise in risk management, deviation handling, and root cause analysis
- Ability to lead cross-functional investigations and drive continuous improvement
- Excellent communication and coordination skills
- Familiarity with validation, qualification, and batch record review processes
Benefits
- Parental benefits
- Employee Assistance Program to promote mental health
- Life insurance for all employees globally
- Flexible working arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMPISO13485ISO14971ISO/IEC 17025risk managementdeviation handlingroot cause analysisvalidation processesqualification processesbatch record review
Soft skills
communication skillscoordination skillsleadershipcontinuous improvementcollaborationcoachingproblem-solvingtrend analysis