Compliance Executive

1 week ago


Petaling Jaya, Malaysia Lufter Sdn Bhd Full time

**Education and Experience**:

- Minimum Bachelor's Degree in Engineering or Science discipline, advanced degree may be an additional advantage.
- Experience in Pharmaceutical or related industry in an advantage.
- Minimum 3 years of working experience in related industry.
- Has a good understanding of QMS and has participated in local or international audits as an auditee, auditor or trainer. Familiarity with ISO 9001 may be an additional advantage.

**Accountabilities**:

- Support all aspects of the validation life cycle from design through operation, improvement and retirement.
- Develop, review and manage project lifecycle documentation with support from experienced validation experts, including Validation Plans, User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Validation Reports, SOPs, Change Control Documentation, Risk Assessments, Validation Deviations and Qualification Reports with relevant stakeholders.
- Coordinate with relevant stakeholders to execute and close validation protocols and procedures to ensure systems meet with appropriate regulatory agency validation requirements, client’s requirement and current company standards.
- Inspect completed work and/or work in progress at sites to ensure conformity of material and works according to specifications and requirements.
- Assist in deviation investigation, resolution of problems and issues encountered during field execution activities.
- Interfacing with customers to develop validation documentation, schedule and communicate results.
- Generation, maintenance, and technical review of standard operational procedures for validation activities.
- Assists in developing validation strategies and training internal personnel on validation method, policies and procedures.
- Support the Quality Management Representative in establishing, implementing and maintaining Quality Management System.
- Develop compliance related procedures, training materials and assist in compliance plans implementation

Pay: RM3,500.00 - RM4,500.00 per month

**Benefits**:

- Cell phone reimbursement
- Free parking
- Health insurance
- Maternity leave
- Parental leave

Schedule:

- Day shift
- Monday to Friday

Supplemental Pay:

- Overtime pay
- Yearly bonus

Work Location: In person


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