Quality Assurance Executive

Private Advertiser; Ipoh; On-site; MYR 100,000 - 150,000; Full time

Job summary

A pharmaceutical company in Ipoh, Malaysia is seeking a Quality Assurance specialist to oversee quality control processes and ensure compliance. The ideal candidate has a relevant degree and at least 3 years of experience in a GMP facility, possessing strong analytical skills and the ability to communicate effectively in multiple languages. Join a collaborative team to drive product quality and safety.

Qualifications

• Minimum 3 years of experience in a related field, especially in a Pharmaceutical industry/GMP facility.
• Understanding of Qualification & Validation processes preferred.
• Ability to communicate effectively in English, Malay, and Mandarin.

Responsibilities

• Responsible for qualification of production equipment and critical utilities.
• Assist in preparing validation protocols and reports.
• Conduct root cause analysis and manage CAPA for non-conformances.

Skills

Analytical skills

Quality control knowledge

GMP understanding

Training delivery

Education

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

Job description

Responsible for qualification of production equipment, premise and critical utilities

Assist in preparing validation/qualification protocols and reports

Assist in investigation and follow up of production issues and deviations

Draft, review, or revise SOP for QA and other departments

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

Participate 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

Requirements

Bachelor's Degree/ Diploma in Food Technology/Nutrition/Science/Biologist/Chemistry/Pharmaceutical, with a minimum of 3 years in the related field is required for this position (Experience in the Pharmaceutical industry / GMP facility is a requirement)

Understanding of Qualification & Validation processes is an added advantage

Required languages: 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 of GMP and good analytical skills and experience in QC laboratory

Experience in training delivery and quality assurance is preferred

Possess a positive attitude, self-motivated and self-disciplined

Well-versed in documentation handling