Associate Executive, Document Controller

2 days ago

Bandar Baru Enstek, Malaysia Novugen Oncology Sdn Bhd Full time

**About us**

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market.

Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

**About the role**

The incumbent of this role is responsible for ensuring effective distribution, issuance, retrieval of all documents in the plant and maintenance of archival room. This role is essential to support audit readiness and ensure the issuance of documents in a timely manner and without disruption.

Key Responsibilities:

- Responsible for collecting supporting documents for Quality Management System (QMS) aspects such as Change Control (CC), Deviation, CAPA, Self-Inspection, Management Review Meeting (MRM), etc.
- Responsible for the control of the documentation system.
- Responsible for document management system through SAP.
- Responsible for document retrieval and archival.
- Responsible for effective issuance of documents, including SOPs, Record of Analysis (ROAs), Specification, Standard Test Procedure, etc.
- Responsible for issuance of Batch Manufacturing Record (BMR), Batch Packing Record (BPR), records, logs, and formats.
- Responsible for the issuance, retrieval, and archival of logbooks.
- Responsible for maintaining the archival rooms.
- Responsible to support the preparation of cGMP schedule, training matrix, and other training-related activities.
- Responsible for supporting review of the PMP and calibration planner and ensuring execution as per the planner.
- Responsible to perform all assigned duties adhering to the standard operating procedures.

**About you**
- Possessed a Degree in a field of pharmaceuticals related.
- Proficient in English and Bahasa Malaysia both written and spoken.
- Related experience from the Pharma, FMCG, and Healthcare industries in QA/QC/Production functions within cGMP environment will be an added advantage.
- High level of integrity and professionalism.
- Proficient in Microsoft Office Suite.
- Must be willing to work in Bandar Enstek, Negeri Sembilan.

**Job Types**: Full-time, Permanent

Pay: RM2,250.00 - RM3,000.00 per month

Schedule:

- Monday to Friday

Work Location: In person

Application Deadline: 07/15/2025
Expected Start Date: 07/28/2025

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