Associate Manager, IPQA

Novugen; Nilai; On-site; MYR 180,000 - 240,000; Full time

Job summary

Novugen, a Malaysia-based pharmaceutical company, seeks an Associate Manager to oversee in-process quality assurance activities within GMP-controlled manufacturing. You will supervise IPQA operations, monitor processes, review batch documentation, and implement CAPA to ensure product quality and regulatory compliance.

You will collaborate with Production, Quality Control, and cross-functional teams to drive continuous improvement and ensure readiness for regulatory inspections.

Qualifications

• Must have strong IPQA knowledge and experience in GMP-regulated pharma operations.
• At least 8 years in pharmaceutical manufacturing with a minimum of 3 years in supervisory roles.
• Solid understanding of end-to-end pharmaceutical production processes.
• Willingness to work at Bandar Enstek, Nilai, Malaysia.

Responsibilities

• Prepare and review SOPs for the QA department.
• Execute day-to-day IPQA activities in line with SOPs.
• Supervise and train staff on SOPs and regulatory requirements.
• Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for batch release.
• Review test results and ensure IPQA compliance with procedures.
• Support QMS activities including change control, deviations, CAPA, and risk management.
• Prepare, review or revise IPQA documents and validation-related records.
• Review qualification and validation documents (process, cleaning, computer systems).
• Assist with internal audits and regulatory inspections.

Skills

IPQA knowledge

Supervisory experience

Quality systems

Education

Bachelor's degree in Science

Job description

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 Associate Manager is responsible for overseeing in-process quality assurance activities within pharmaceutical manufacturing to ensure compliance with GMP, regulatory requirements, and established quality standards. The role involves supervising IPQA operations, monitoring manufacturing processes, reviewing batch documentation, investigating deviations, and implementing corrective and preventive actions (CAPA). The position also works closely with Production, Quality Control, and other cross-functional teams to ensure product quality, maintain compliance, and support continuous improvement in manufacturing operations.

Key Responsibilities:

• Prepare and review the Standard Operating Procedures (SOPs) of the Quality Assurance department.
• Execution of day-to-day In-Process Quality Assurance (IPQA) activities adheres to Standard Operating Procedures (SOPs).
• Supervise and train employees on matters related to SOPs and regulations.
• Sample drawings of blends, intermediates, and finished goods adhere to Standard Operating Procedures (SOPs).
• Review the Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), and other relevant documents for batch release.
• Responsible for the approved and rejected batches.
• Review the executed and master batch records to ensure it is aligned with related established procedures, master manufacturing formula, and other relevant documents.
• Review and approve test results of products undergoing In-Process Quality Assurance (IPQA) adheres to Standard Operating Procedures (SOPs).
• Prepare, execute, review, and approve the In-Process Quality Assurance (IPQA) documents and other documents related to product operations.
• Enforce overall cGMP compliance that consists of data integrity and Good Documentation Practices (GDP) during batch documentation and process execution.
• Review and supports QMS activities such as change control, and deviation. investigations, corrective action and preventive action, quality risk management, out-of-specification, out-of-trend, annual product quality review, market complaints, and product recall.
• Execute self-inspection and internal audit follows the organizational requirements.
• Provide support during external or regulatory authority inspections.
• Recommend continuous improvement plans based on observation of process, quality data, etc.
• Prepare, review or revise APEX documents such as the Validation Master Plan (VMP), and Site Master file.
• Review and approve all documents related to qualification, and validation including process validation, cleaning validation, computer system validations, and hold time study.
• Review and approve miscellaneous documents related to operation i.e., study plan, sample request form, test request form, and document request form.

About You

• Must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, or Master's Degree in Science (Chemistry, Pharmaceutical Technology, Biotechnology)
• At least 8 years of working experience preferably in Pharmaceutical Manufacturing with a minimum of 3 years of supervisory experience.
• A strong understanding of In-process Quality Assurance (IPQA) activities is a must
• Knowledge of end-to-end pharmaceutical production processes.
• Must be willing to work in Bandar Enstek, Nilai