全职 Engineering Executive – Compliance 工作, 薪水 up to MYR 3,600, Kenanga Network Selangor 公司招聘中 - Ricebowl

1. Compliance & Regulatory Oversight

· Ensure Engineering activities comply with GMP, GDP, GDPMD, EHS regulatory authority requirements (NPRA, PIC/S, FDA, etc.).

· Act as compliance lead for Engineering during internal, external, and regulatory audits.

· Manage and maintain engineering documentation (SOPs, logs, validation protocols, calibration records) in accordance with data integrity and document control standards.

· Perform periodic self-inspections and gap assessments; drive corrective and preventive actions (CAPA).

· Lead and manage Quality Risk Assessments related to engineering functions and utilities.

2. Calibration Program Management

· Oversee and manage the site-wide calibration program to ensure timely and accurate calibration of critical instruments and equipment.

· Maintain the calibration master list and ensure calibration certificates are reviewed and filed.

· Liaise with vendors and internal technicians for scheduling, execution, and verification of calibration work.

· Investigate out-of-tolerance (OOT) events and coordinate necessary corrective actions.

3. Commercial/Procurement Support

· Support engineering budget planning, cost tracking, and cost-saving initiatives.

· Participate in vendor qualification and assessment for calibration, maintenance, and engineering services.

· Review and approve engineering service contracts, calibration service agreements, and procurement specifications.

· Monitor contract compliance, vendor KPIs, and ensure value-for-money service delivery.

4. Project Support & Documentation

· Provide compliance support for new equipment installations, engineering projects, and facility modifications.

· Review and approve URS, IQ/OQ/PQ protocols, change controls, and deviations involving engineering scope.

· Ensure all engineering changes are assessed for regulatory and quality impact.

5. Training & Continuous Improvement

· Train engineering staff on compliance, GMP practices, and calibration procedures.

· Promote a quality and compliance culture within the engineering team.

· Lead or support continuous improvement initiatives (e.g., 5S, LEAN, Quality Metrics, etc.)

• To undertake any other duties as directed by the Immediate Supervisor and Management as and when required.

Pay: RM2,700.00 - RM3,600.00 per month

Benefits:

• Additional leave
• Dental insurance
• Flexible schedule
• Free parking
• Health insurance
• Maternity leave
• Meal allowance
• Opportunities for promotion
• Professional development
• Vision insurance

Ability to commute/relocate:

• Rawang: Reliably commute or planning to relocate before starting work (Required)

Application Question(s):

• Do you have any working experience in Engineering Compliance?

Education:

• Bachelor's (Required)

Work Location: In person