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Traineeship - QA Engineer
2 weeks ago
Job Summary:
The Quality Engineer is to promote and integrate quality aspect into every aspect of our quality systems and processes to ensure that all products and processes meet approved company policies, quality standards and comply with regulatory requirements. This role is essential in maintaining the integrity of the manufacturing process, ensuring quality products for customers.
Essential Duties and Responsibilities:
- Follow Standard Operating Instructions (SOI) and Good Manufacturing Practices (GMP) in daily tasks.
- Ensure compliance with Global Policies, Procedures, Guidelines, and regulatory requirements.
- Lead and support quality system implementation as appropriate.
- Review and approval of documents, including SOPs, protocols, reports, product specifications.
- Lead and act as subject matter expert in change management including lead/participate in cross functional risk assessment and provide guidance in change management process.
- Review and approve deviations, OOS, and CAPA. Ensure timeline closure of the quality system records. Perform trending and work with stakeholders to address negative trends.
- Review risk assessments and recommend product dispositions.
- Perform supplier assessment and qualification.
- Set-up inspection plan in SAP system.
- Support equipment qualification of new and advanced technologies.
- Perform regular walk through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained.
- Proactively seek to improve and simplify site processes and procedure, to ensure compliance is maintained at all times.
Education and Experience:
- Bachelor's degree or equivalent experience in Science, Engineering, or a related discipline.
- 2 to 5 years of experience in quality control and/or quality assurance in a manufacturing environment.
Knowledge, Skills and Abilities:
- Basic understanding of cGMP requirement and quality mindset is an advantage.
- Good understanding of Annex 1 requirement is an advantage but not required.
- Familiarity with ISO 15378 and ISO 9001 is advantageous but not required.
- Excellent attention to detail and demonstrate commitment and proactiveness in tasks assigned.
- Prior experience in primary packaging materials manufacturing environment is advantageous but not required.
- Good communication and teamwork skills.
