Senior Executive - Compliance (Quality)
RM 4,500 - RM 5,500 / month
Checking job availability...
Original
Simplified
Education and Experience:
- Bachelor's degree in Engineering, Construction Management, Business Administration, or a related field.
- Familiarity with cleanroom construction regulations and standards is an advantage.
- Minimum 3 years of working experience in related field.
- Experience in conducting compliance audits, risk assessments, and process evaluations.
- Has a good understanding of quality management systems and has participated in local or international audits as an auditee, auditor or trainer. Familiarity with ISO 9001 is an advantage.
- Proven track record of effectively collaborating with cross-functional teams and stakeholders.
- Knowledge of relevant compliance software and tools.
Job Description:
- 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.
- Collects, analyzes and present quality objective results to all stakeholders.
Job Type: Full-time
Pay: RM4,500.00 - RM5,500.00 per month
Benefits:
- Cell phone reimbursement
- Free parking
- Health insurance
- Maternity leave
- Parental leave
Schedule:
- Day shift
- Monday to Friday
Supplemental Pay:
- Performance bonus
Education:
- Bachelor's (Preferred)
Experience:
- QA/QC: 3 years (Preferred)
Work Location: In person