Kerja Sepenuh Masa, Quality System - Compliance Executive di Kossan Latex Industries (M) Selangor - Maukerja

DUTIES AND RESPONSIBILITIES:

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.

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.

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.
• 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

• Observe the company policy and follow the company safety rules and regulations in daily work.
• Other assigned duties as required by his/her superior.

JOB REQUIREMENTS:

Qualification

• Minimum Bachelor’s Degree in Science /Chemical Engineering/ Mechanical Engineering/ Chemistry or equivalent.

Experience

• 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

• Knowledge in medical devices, validation, audit, quality management system, cGMP and FDA in a regulated environment.
• Knowledge and experience in medical device regulations, ISO 9001 and ISO 13485 quality management systems and good manufacturing practices.
• Possess good communication and interpersonal skills.
• Possess right attitude and good discipline.
• Able to work independently with minimum supervision.

Benefits:

• Free parking
• Health insurance

Application Question(s):

• What is your expected salary?
• Are you willing to work in Meru, Klang?

Work Location: In person