Quality Assurance Executive

Jobstreet Malaysia; Ipoh; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading company in the pharmaceutical sector, located in Ipoh, Malaysia, seeks an individual for a quality assurance role. The successful candidate will oversee quality processes, ensure compliance, and needs to hold a relevant degree with a minimum of 3 years' experience in a GMP facility. Proficiency in English, Malay, and Mandarin is essential for communication with clients. This role offers a dynamic work environment with responsibilities in quality control and validation.

Qualifications

• Minimum 3 years of experience in the pharmaceutical industry or GMP facility is required.
• Understanding of Qualification & Validation processes is an added advantage.

Responsibilities

• Responsible for qualification of production equipment and critical utilities.
• Oversee quality control processes and batch release procedures.
• Collaborate with Production and R&D to ensure compliance.

Skills

Quality control processes

GMP understanding

Analytical skills

Communication skills in English, Malay, Mandarin

Training delivery

Education

Bachelor's Degree/ Diploma in food Technology/Nutrition/Science/Biology/Chemistry/Pharmaceutical

Job description

Overview

• Responsible for qualification of production equipment, premise and critical utilities
• Assist prepare validation/qualification protocols and reports
• Assist in investigation and follow up of production issues and deviations
• Drafts, review, or revises SOP for QA and other department
• Oversee quality control processes, batch release procedures and documentation
• Conduct root cause analysis and manage CAPA (corrective and preventive actions) for non-conformances
• Collaborate with Production, R&D department and warehouse to ensure quality compliance across departments
• Participants in product complaint investigation and ensure proper documentation and resolution
• Perform Qualified Personnel duties, including reviewing, verifying, and signing off on testing/analytical reports and batch manufacturing documents. Release or reject materials for production and finished product sales, as delegated by the Head of Department
• Responsible for final release of finished product in the absence of Quality Manager
• To ensure that only passed and approved finished products can be released by issuing the "Approved Sticker" on the finished product
• To control supplier performance periodically for evaluation purposes
• Responsible for JKKP inspection preparation and audit
• Performs tasks as per instructed by superior whenever required

Qualifications

• Bachelor's Degree/ Diploma in food Technology/Nutrition/Science/Biologist/Chemistry/Pharmaceutical, with minimum 3 years in the related field is required for this position (Experience in Pharmaceutical industry / GMP facility is a requirement)
• Understanding of Qualification & Validation processes is an added advantage
• Required language(s) : English, Malay, Mandarin to effectively communicate with Mandarin-speaking clients.
• Able to work independently, multi-task and collaborate well with other team-members
• Good understanding in GMP and good analytical skills and experience in QC laboratory
• Experience in training delivery and quality assurance is preferred
• Possess positive attitude, self-motivated and self- discipline