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QA Inspector

Xepa-Soul Pattinson (Malaysia) Sdn BhdMelaka, Melaka, Malaysia

1 hari lalu

Penerangan pekerjaan

Position : In Process Quality Assurance (IPQA) Inspector

Workbase : Cheng, Melaka.

Job Outline :

Responsible to conduct sampling for inspection manufactured work in progress and finished goods, using established procedures to meet specification and quality standard for laboratory testing and retention.
Responsible to monitor, generate and maintain in process quality records in order to keep track on in process quality.
Responsible to investigate defective work in progress and finished goods in production line by determining the relevance of types of defects (Not Admissible, Critical, Major & Minor) and report the observations immediately to superior for further action.
Responsible to implement, practice and observe cGMP compliance in work practices and routine activities.
Responsible as respective In Process Quality Assurance (IPQA) subject matter expert for whereby can effectively communicate among team member regarding IPQA issue and shall be independent in decision making on quality related matter before consulting superior. Shall plan accordingly in term of task delegations to the team member and observe the performance and ensure the task is completed as per planned and without any mistakes.

Duties and Responsibilities :

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 in the production work centers and lines.

To manage usage, cleaning and housekeeping of sampling tools and test equipment.

To perform in-house verify 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 escalate to the Superior in the event of Non-conformance, failure, deviation or any abnormalities and participate in investigations.

Minimum Requirements :

Diploma (in Pharmacy, Chemistry, Microbiology or Engineering) or Sijil Pelajaran Malaysia with minimum two years working experience in the quality assurance, quality control or related functions in a manufacturing operation.

Experience in the Quality Assurance section for pharmaceutical and prior statistical background will be an added advantage.

Basic knowledge of ISO and PIC / S regulations and cGMP is required.

Good communication skills (speaking and writing in English and Malay language) and able to work independently.

Proficient in Microsoft office applications (Microsoft Word / Excel etc.)

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Qa Inspector • Melaka, Melaka, Malaysia