全职 Executive, IPQA 工作, 薪水, Novugen Negeri Sembilan 公司招聘中 - Ricebowl

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 Associate Executive, IPQA plays a critical role in overseeing the quality of product manufacturing in the facility. The chosen candidates will be carrying out all the processes as per standard operating procedures during manufacturing to ensure quality by performing the routine production rounds and to ensure compliance during Line clearance, Material verification, and Sampling stages of manufacturing and packing of the product.

Key Responsibilities:

Responsible for performing line clearance activities and in-process checks at production.

Responsible for collecting in-process samples, control samples, finished product samples, stability samples, validation samples, hold time study samples, and swab samples.

Responsible for shopfloor compliance.

Responsible for review of executed Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).

Responsible to review of master production records such as BMRs and BPRs.

Responsible to prepare protocol and report of cleaning validation, process performance qualification, and hold time studies.

Responsible for execution and monitoring of cleaning validation, process performance qualification, and hold time studies.

Prepare and review the standard Operating Procedure (SOP) that related QA and PD Department.

Responsible to initiate and being involved in QMS documents like Change Control, Deviation, CAPA, and Failure investigation documents.

Responsible for involving in risk assessment/risk management activities.

Responsible for the archival of executed documents such as executed BMRs, BPRs and other related documents.

About You

• Candidate must possess at least a Bachelor's Degree in Science (Chemistry, Pharmaceutical Technology, Biotechnology).
• 2-3 years of relevant working experience, preferably in Pharmaceutical Manufacturing.
• Fresh graduates with relevant internship exposure are encouraged to apply.
• Willing to work on a shift schedule.