Senior Quality Assurance Executive
Full-time
Senior Executive
2 months ago
Job Description:Ensure compliance with GxP, GMP, ISO and regulatory requirementsManage quality systems including CAPA,deviations, change control, and.....
Job Description:
- Ensure compliance with GxP, GMP, ISO and regulatory requirements
- Manage quality systems including CAPA,deviations, change control, and customer/supplier complaints
- Support qualification and validation activities (IQ/OQ/PQ, risk assessments, documentation review)
- Conduct internal audits and support external audits, customer audits and regulatory inspections
- Review batch records, perform material and product release (SAP), and issue COA
- Maintain SOPs, quality documentation and support regulatory submissions
- Perform root cause analysis and drive continuous quality improvement initiatives
- Manage supplier qualification andsupport training on quality standards
- Support ongoing QA activities, projects and ad hoc duties
Job Requirements:
- Degree in Pharmacy, Food Science or related field
- Minimum 5 years of QA experience in manufacturing (food, pharma, or chemical industry preferred)
- Knowledge of GMP, GxP, ISO 9001 / FSSC22000
- Experience in audit, validation and quality system
- Possess experience in internal audit, validation activities, training management and batch release for API with good background on cGMP
- Strong analytical, problem-solving and communication skills
- Meticulous, organised and able to work under pressure
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