Associate Quality Assurance

Alcon; Johor; On-site; MYR 100,000 - 150,000; Full time

Job summary

A multinational medical company located in Johor, Malaysia, seeks a regulatory compliance officer to perform complaint sample verifications and ensure all quality standards are met. Responsibilities include investigating nonconformances, generating CAPAs, and working on special projects. Ideal candidates should possess strong communication skills and be well-versed in calibration and verification processes. This role offers the opportunity to impact product quality while adhering to company standards and regulations.

Qualifications

• Experience in performing complaint sample verifications with quality standards.
• Knowledge in equipment calibration and verification processes.
• Strong communication skills for interactions with internal and external contacts.

Responsibilities

• Perform complaint sample verifications and complete documentation.
• Conduct regular equipment standardizations and ensure compliance.
• Investigate nonconformances and identify CAPAs as necessary.

Skills

Complaint sample verifications

Calibration and verification requirements

Effective communication

New equipment qualification

Job description

Job Purpose

Perform complaint sample verifications and complete documentation related to complaint sample verifications. Conduct regular equipment standardizations. Develop, review and revise SOPs, Forms, and Wis. Identify and investigate nonconformances. Generate and execute CAPAs as needed. Execute special projects assigned.

Major Accountabilities

• Inspections of complaint samples are accomplished per SOP and quality standards, while meeting the productivity thresholds.
• Ensure instruments are compliant with calibration / verification requirements as stated by Alcon and/or manufacturer guidelines.
• Assigned NCRs are adequately investigated and CAPA’s are appropriately identified and completed on time.
• Interacts with internal and external contacts to provide clear, straightforward, effective, and factual communication and information.
• Responsible in new equipment qualification.
• Maintains awareness of the roles of immediate team members and the work function.
• Responsible to adhere to the Alcon Code of Business Conducts and Alcon Health, Safety and Environment Standards.
• Responsible to observe and ensure full compliance with Information security policy.

Key Performance Indicators

• Samples verification completion – zero overdue
• Samples delivery to AVS/FTW – as per estimate arrival plan
• Analyst qualification completion – within 3 months upon assigned
• New Equipment Qualification completion – within project timeline

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