Quality Assurance Inspector

Xepa-Soul Pattinson (Malaysia) Sdn Bhd; Malacca City; On-site; MYR 33,000 - 58,000; Full time

Job summary

Xepa-Soul Pattinson (Malaysia) Sdn Bhd is seeking a Quality Assurance Inspector to join our Malacca site. You will conduct in-process quality checks, sampling, and documentation in line with IQS/QMS requirements to support production startup and ongoing operations.

You will ensure compliance with ISO9001, ISO13485, EU GMP and ALCOA data integrity principles, maintain quality records, coordinate laboratory testing, and assist investigations into non-conformances under supervision.

Qualifications

• Familiar with GMP, GLP and quality systems.
• Ability to perform sampling and inspections per SOPs.
• Knowledge of environmental monitoring principles.

Responsibilities

• Adhere to ISO9001, ISO13485, EU GMP and other applicable standards in QC tasks.
• Coordinate sampling and submission to QC laboratory for testing.
• Perform in-process quality inspection on WIP and finished goods.
• Assist root cause investigations for non-conformances and CAPA.
• Maintain and organize quality records and documentation.
• Escalate non-conformances to supervisor and participate in investigations.

Skills

GxP compliance

Good Documentation Practices

In-process quality inspection

Environmental monitoring

ALCOA data integrity

Tools

Test equipment handling

Job description

• To adhere on compliance to safety rules, Good Documentation Practices, ISO9001, ISO13485, EU GMP, PICs/GMP and other applicable Standards in Xepa-Soul Pattinson.
• To ensure alertness and readiness on ALCOA concepts among the team for example logbooks usage adherence and update, time stamp, on real time recording, adhere to the written and approved procedure and etc.
• To conduct sampling and perform in process quality inspection on work in progress and finished goods that require in process quality control checks following appropriate procedures and specifications for production startup and continuation.
• To coordinate the sample collection and submission to Quality Control laboratory for testing and retention.
• To perform environmental monitoring according to the predetermined schedule and ensure environmental monitoring program and supporting procedures adhered to standard operating procedures.
• To assist in root cause investigation in quality non-conformance for testing and test method discrepancies and involve in corrective action implementation related to IPQA activities.
• To manage usage, cleaning and housekeeping of sampling tools and test equipment.
• To perform in-house verification on all test equipment according to predetermined schedule and standard operating procedure.
• To generate and maintain quality records for all documents related to the department.
• To assist and support for other additional tasks given by the superior.
• To escape to the Superior in the event of Non-conformance, failure, deviation or any abnormalities and participate in investigations.

At Xepa, ideas, people and technology are put together to create trusted, high-quality affordable medicines. We are a pharmaceutical company with a distinct and true commitment - Xepa products help people live healthier, longer and more productive lives.

Founded in 1967 in Singapore, Xepa has grown and evolved at the forefront of the industry. From our modest first years where Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products out of a small flatted factory, we’ve relocated, twice, accommodating expansion to larger manufacturing plants in Malacca, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.

At Xepa, ideas, people and technology are put together to create trusted, high-quality affordable medicines. We are a pharmaceutical company with a distinct and true commitment - Xepa products help people live healthier, longer and more productive lives.

Founded in 1967 in Singapore, Xepa has grown and evolved at the forefront of the industry. From our modest first years where Xepa Laboratories Pte. Ltd. produced a limited range of pharmaceutical products out of a small flatted factory, we’ve relocated, twice, accommodating expansion to larger manufacturing plants in Malacca, Malaysia. Today, Xepa is the leading manufacturer of off-patent pharmaceuticals in Malaysia.

What can I earn as a Quality Assurance Inspector