Quality Assurance Specialist
4 months ago
Responsibilities
Implement, maintain and improve company’s QMS effectively based on ISO 9001, ISO 22716, Good Manufacturing Practice (GMP), Good ..
Responsibilities
- Implement, maintain and improve company’s QMS effectively based on ISO 9001, ISO 22716, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and relevant Halal guidelines effectively.
- Contribute for and coordinate change management, risk management, continuous improvement and quality objectives monitoring with relevant functions.
- Prepare for and coordinate Management Review meeting.
- Conduct quality induction/quality-related training sessions for team members and other relevant parties when required.
- Ensure and maintain proper quality system document control including procedure review and improvement based on document system.
- Organise and conduct quality internal and external audits based on audit schedule and required ISO 19011 guidelines.
- Reporting of audit results and the proposed changes to QMS-related procedures when necessary.
- Evaluate the impact of quality deviations on operations and the need for corrective and preventive actions (CAPA).
- Utilise customer feedback, conduct customer satisfaction monitoring and report customer satisfaction results based on customer satisfaction system.
- Coordinate with QC for the investigation of product feedbacks from different regions, analyse quality problems and recommend problem resolution.
- Work with relevant functions to provide evaluation for the selection and ongoing performance of external providers; monitor and ensure required improvement of external providers based on external provider quality management (EPQM).
Requirements
- Bachelor’s degree in Science or Engineering (preferably in Quality Management, Cosmetic Science, Chemistry, Pharmacy, or relevant engineering).
- Preferably 2 years of working experience in quality-related functions. Fresh graduates are welcome to apply too.
- Good knowledge of tools, concepts and methodologies of QA.
- Experience in quality auditing, implementation of CAPA and quality improvement projects preferred.
- Experience in a GMP environment or knowledge of GMP and/or ISO 9001 a plus.
- Certifications such as Quality Auditor/Quality Engineer will be an advantage.
- Stringent compliance to procedures, guidelines, standards and regulations.
- Strong computer skills including Microsoft Office, QA applications and databases.
- Self-starter, good at working well independently with initiatives.
- Meticulous and detail-oriented.
- Good analytical and problem-solving skills.
- Effective planning, coordination, interpersonal and negotiation skills.
- Time management skills (scheduling, prioritising) to meet deadlines.
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