Executive, Analytical Quality Assurance

**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, impact lives across the world.

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

**About the role**

The role will be responsible for execution of the day-to-day Analytical Quality Assurance activities at Novugen Pharma Sdn Bhd.

Key Responsibilities:

- Ensure Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) is in place and facilitate audit requirement for Quality Control.
- To review the Standard Operating Procedures (SOPs), Standard Testing Procedure, Specifications and Record of Analysis related to Quality Control.
- Responsible for conducting the cGMP walkabout in Quality Control & Microbiology Laboratory to ensure Quality Control Laboratory compliance.
- To review and approve all qualification, method validation and method verification documents for Quality Control.
- To review and approve protocol and report for comparable multimedia dissolution profile.
- To review and approve Out of Specification investigation, Out of Trend, Deviation and Laboratory incident and proposed CAPA for Quality Control.
- To review Quality Control Analytical Test Report and Certificate of Analysis.
- To review all documents and Analytical Test results pertaining to Cleaning Validation (CV) / Hold Time study (HTS)/Process Validation (PV) / Exhibit, Scale up and commercial batch.
- Responsible to review the Quality Control related to change control and documents revision.
- To review and monitor overall activities related to QMS such as change control, deviation, corrective action and preventive action, Quality Risk Management, Annual Product Quality review, Market complains, Product recall, etc.
- To participate and provide support during external and regulatory authority inspection.
- To prepare and review the Standard Operating Procedures (SOPs) related to Quality Assurance.
- To provide support in Internal Audit.
- To issue and control distribution of forms and etc.
- To monitor and handle of Reference samples, Control Samples and Test Samples at QA Reference Samples area.
- Perform other related duties as assigned by reporting manager from time to time based on organizational needs.
- Responsible for conducting periodic instrument audit trail review activity. (Empower and standalone instrument)

**About you**
- Minimum 3 years of working experience preferably in Pharmaceutical Manufacturing/ Medical Device industry.
- Good technical knowledge and exposure in handling Lab Instruments.
- Proficient in Microsoft Office Suite.
- Able to work in shift.
- Must be willing to work at Bandar Baru Enstek, Negeri Sembilan.

Pay: From RM2,700.00 per month

Work Location: In person