Junior Quality Assurance Executive

Duties and Responsibilities:
1. Batch Manufacturing Record (BMR) Management
Issuance, reconciliation, review, and control of Batch Manufacturing Records (BMR).
-Preparation and maintenance of production-related documentation.
-Review of batch documentation for completeness and GMP compliance.
-Preparation and management of reprocessing records and supporting documents.
-Support batch release activities and documentation compliance.

2. Training Management
-Coordinate and monitor employee training programs.
-Maintain and update training records and competency matrices.
-Ensure training compliance with GMP, SOPs, and company requirements.
-Track training effectiveness and completion status.

3. Document Control Management
-Administration of Document Management System (DMS).
-Control, issuance, distribution, retrieval, and archiving of controlled documents.
-Management and revision of SOPs, Master Manufacturing Formula (MMF), Packaging Instructions (PI), and quality documents.
-Artwork control and version management.
-Maintenance of electronic systems related to documentation and packaging.
-Ensure document traceability, version control, and regulatory compliance.
-Support document updates arising from changes, deviations, investigations, and improvement initiatives.

Minimum Requirements:
1. Preferably Degree in Pharmacy, Chemistry, Microbiology, Science or Engineering, with minimum two years (QA Executive II) and three years (QA Executive I) working experience in the quality assurance, quality control or related functions in a manufacturing operation.

2. Experience in the management of Quality Assurance Programs for pharmaceutical and prior statistical background will be an added advantage.

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

4. Excellent interpersonal and communication skills (speaking and writing in English) and able to work independently.

5. Attention to detail, possess planning and organizing skills, judgment skills and decision-making skills.

6. Proficient in Microsoft Office applications.