Assistant Manager, IPQA

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 Assistant Manager, In-Process Quality Assurance (IPQA) is responsible for overseeing the quality of product manufacturing in the facility. Incumbent 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 product.

This role will be based at Novugen Oncology Manufacturing Plant in Bandar Baru Enstek, Negeri Sembilan.

Key Responsibilities:

• Responsible for review and approval of master production records, like master formula records, batch manufacturing records, and batch packaging records.
• Responsible for compilation/Preparation/review of protocols and reports related to process validation and cleaning validation/verification.
• Responsible for review and approval of executed BMR's and BPRs, completeness and review of documents related to batch release.
• Responsible for performing process checks and collecting In-process samples, Control samples, Retention samples, stability samples, validation samples etc.
• Responsible for reviewing various Operating Procedures (SOP) related to the QA Department.
• Prepare, maintain, and update validation and compliance documents, such as SMF, VMP, SOPs, protocols etc.
• Responsible for the preparation/review of the Annual Product Quality Review (APQR).
• Responsible for the preparation/review of Quality System (QS) aspects such as Change Control (CC), Deviation, CAPA, Self-Inspection, Failure Investigation, and Management Review Meeting (MRM)
• Responsible for quality system planning, implementation of cGMP in the plant, and maintaining compliance with regulatory requirements.
• Responsible for review and approval of various validation protocols related to cGMP compliance.
• Responsible for conducting audits of various other department records and logs relevant to manufacturing and packaging activities.
• Responsible for the training of personnel.
• Responsible for the preparation of risk assessment/risk management activities.
• Responsible for the preparation of investigation reports.
• Responsible for the preparation of SOPs pertaining to the standard operating procedures.

About you

• Candidate must possess at least a Bachelor's Degree in Science (Chemistry, Pharmaceutical Technology, Biotechnology).
• Minimum 5 years of relevant working experience, preferably in Pharmaceutical Manufacturing with 2 years of supervisory role.
• Exposure in OSD is a must.
• Proficient in Microsoft Office Suite.
• Able to work in shifts.
• Must be willing to work at Bandar Baru Enstek, Negeri Sembilan