Quality Assurance Executive

Abbott Laboratories; Petaling Jaya; On-site; MYR 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Quality Management professional. The role involves ensuring compliance with local and corporate regulations, preparing for audits, and supporting quality strategies. Ideal candidates will have a strong educational background in science and experience in the medical device industry. A commitment to teamwork and effective communication are essential.

Qualifications

• Minimum of Bachelor’s degree in Science required.
• Experience in Commercial Quality within Medical Device or Pharmaceutical sector preferred.
• Strong written and oral communication skills in local language and English.

Responsibilities

• Support in developing and monitoring Quality Compliance strategies.
• Manage document control for QMS procedures and quality records.
• Prepare for Internal & External Quality & Compliance Audits.

Skills

Interpersonal skills

Time management

Communication Skills

Detail-oriented

Teamwork

Education

Bachelor’s degree in Science

Tools

Word

Excel

PowerPoint

Job description

PRIMARY OBJECTIVE:
Responsible for Quality Management system and to be 100% compliance with Corporate, Divisional and local regulations.

CORE JOB RESPONSIBILITIES:

• Support in developing, implementing, assuring and monitoring the Quality and Regulatory Compliance strategies of the company
• Supports Complaint Handling/ post market surveillance and follow up actions
• Assignment of QMS training to employees on quality related documents and policies
• Preparation of monthly KPI data
• Provide inputs for Management Review Meeting including updates on adequacy and effectiveness of Quality Management system.
• Manages the document control for QMS procedures and quality records
• Support and prepare affiliate for Internal & External Quality & Compliance Audits.
• Prepare and help to obtain and maintain the GDPMD Certification and/or applicable Quality related certification in the region.
• Support external, internal and supplier audit and the follow-up remediation plan.
• Support investigation, defining root-cause and implementation of Corrective Action and Preventive Actions in a timely manner.
• Execution of Product Stop Shipment, Field Safety Corrective Actions as per instructions from Regional or Divisional QA.
• Interacts on a periodic frequency with Commercial, Regulatory Affairs, Supply Chain, Technical Service, Education and other functions on all quality related matters.
• Manage the change control process to meet amendment to local regulatory compliance requirements.
  OTHER FUNCTIONS AND RESPONSIBILITIES:
• Perform various administrative functions as required.
• Any other activities as assigned time to time by Line Manage

EDUCATION/QUALIFICATIONS/EXPERIENCE:

• Minimum of Bachelor’s degree in Science. Equivalent education/work experience will be considered.
• Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.
• Knowledge of local Medical Device regulations
• Computer proficiency in Word, Excel and PowerPoint.
• Strong interpersonal skills, with the ability to build and maintain relationships.
• Effective time management - well organized, able to set and reset priorities
• Strong oral and written communication skills.
• Detail and deadline oriented.
• Conversant local language as well both written and spoken English.
• Ability to work and flourish in a fast-paced multi-tasked environment
• Demonstrates a highly positive attitude concerning risk, change and unexpected challenges.
• Tendency to be friendly, cooperative, agreeable. To be a team person. Promotes the benefits of teamwork and cooperation. Is usually willing to share resources and information.
• Good in English Communication Skills

EXPERIENCE REQUIRED:

• Working experience in a Commercial Quality environment in Medical Device or Pharmaceutical organization will be of advantage.