Quality Assurance Executive

1 week ago

Klang, Malaysia IDEAL QUALITY SDN BHD PLANT 3 (SUBSIDIARIES OF KOSSAN GROUP) Full time

**JOB RESPONSIBILITIES**

**1.** **Process Validation**
- Planning, developing, implementing and monitoring company's validation activity
- Prepare validation master plan, validation protocol and validation report (IQ, OQ, PQ) for process validation
- Coordinate among all relevant personnel and ensure the validation system is executed as per the procedure
- Track and report timelines and milestones related to validation activities
- Compile and review validation result and update the validation status
- CAR issuance & follow up reply & verify action effectiveness for validation failure
- Work with respective PIC on the CAR investigation
- Maintain effective filling system for record retention on validation activities
- Ensure prevention of unauthorized disclosure of company’s confidentiality information.

**2.** **Shelf Life Study**
- Coordinate with prepacking personnel for shelf life study sample preparation
- Liaise with lab personnel on the lab test arrangement
- Liaise with prepacking personnel on the glove inspection (visual, WTT, dimension, donning)
- Prepare shelf life protocol and final report and ensure the study is conducted as per the procedure
- Compile all the inspection result and lab test result and summarize the shelf life study status in the final report

**3.** **Risk Management**
- Preparation of risk management plan and risk management file as per the procedure
- Compile risk analysis and FMEA
- Review and update the risk management file for any update of the risk analysis and FMEA in time
- Review and update FMEA based on complaint received and/or any new risk identified in the process.

**4.** **Technical Documentation**
- Liaise with all the related personnel on the document preparation such as external lab test report, declaration of conformity, general safety and performance requirements (GSPR), related product specification & etc
- Compilation of all the related documents in time
- Prepare the technical documentation file as per the procedure
- Review and update the technical documentation as and when are relevant and required

**JOB REQUIREMENT**

**QUALIFICATION AND EXPERIENCE**
- Minimum Bachelor’s Degree in Science /Chemical Engineering/ Mechanical Engineering/ Chemistry or equivalent.
- Minimum 3-5 years’ working experience in related field.
- Knowledge and experience in medical device regulations, validation, audit, risk management, ISO 9001 and ISO 13485 quality management systems, cGMP and FDA in a regulated environment.

**OTHER PERSONAL CAPABILITIES**
- Good discipline and attitude, proactive and good initiatives.
- Good written and oral communication skills
- Good interpersonal skills.
- Good analytical, problem-solving skills and decision making.
- Ability to manage, result orientated, have good time management and resourceful.
- Ability to work independently with minimum supervision.
- Strong computer skills are preferred.

**Job Types**: Full-time, Permanent

**Salary**: Up to RM4,000.00 per month

**Benefits**:

- Free parking
- Health insurance

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus
- Yearly bonus

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