Novugen Pharma Hiring! Full Time Executive, Quality Assurance (QMS) in Selangor, Earn up to MYR 2,800 - 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

Senior Executive, Quality Assurance (QMS) is responsible for Quality Assurance and QMS compliance in pharmaceutical manufacturing. Key tasks include SOP management, cGMP adherence, change control, CAPA, qualification/validation, audits, and regulatory inspections. Requires strong documentation skills, attention to detail, and ability to drive continuous improvement while ensuring compliance with industry standards.

Key Responsibilities:

• Prepare and review the Standard Operating Procedures (SOPs) related to Quality Assurance.
• Provide trainings on SOPs and other current Good Manufacturing Practices (cGMP) topics with respect to continuous quality improvement programs.
• Support review of drawings and layouts for equipment and manufacturing facility.
• Support QMS-related activities such as handling of Change Control, Deviation, and Corrective Action Preventive Action (CAPA), Annual Product Quality Review, Market Complaints, Product Recall, Adverse Drug Event, and Internal Audit.
• Prepare, review, and revise the Site Master File, Qualification/Validation protocol, and related Standard Operating Procedures.
• Prepare and review all documents pertaining to Quality Management System (QMS).
• Execute self-inspection or internal inspection as per organizational requirements.
• Prepare, execute, and review all documents related to qualifications and validations, including Utilities, Equipment, Instruments, Processes, and Systems.
• Prepare trend reports related to QMS for management review, such as change control, deviation, corrective action and preventive action, market complaints, product recall, etc.
• Responsible for Artwork management.
• Provide support during external or regulatory authority inspections.
• Recommend continuous improvement plans based on observation of process, vendor, and quality data.
• Ensure equipment, instruments, systems, and facility remain in a qualified state based on updated regular requirements by monitoring timely execution of routine re-qualifications as per the calendar or after major modifications.

About you

• Candidate must possess at least Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related field.
• Additional certification in Quality Assurance, cGMP, or Regulatory Compliance is an advantage.
• Minimum 2* years of experience* in Quality Assurance or Quality Management within a pharmaceutical manufacturing environment with strong knowledge of pharmaceutical regulatory requirements and quality standards.
• Must be willing to work at Bandar Baru Enstek, Negeri Sembilan.

Job Type: Full-time

Pay: From RM2,800.00 per month

Application Question(s):

• How long is your notice period?
• What is your salary expectation?

Experience:

• Pharmaceutical Manufacturing: 2 years (Preferred)

Work Location: In person