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Jobs or company...
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Executive, In-Process Quality Assurance

RM 2,800 - RM 3,500 / month
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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 In-Porcess Quality Assurance activities at Novugen Oncology Sdn Bhd.

Key Responsibilities:-

  • Prepare, maintain, or review, validation and compliance document, such as SMF, VMP, SOPs, protocols, training.
  • To generate, plan, execute and reports on qualification and validation protocols of facilities, equipment, software / system, cleaning, processes and so on according to cGMP, USFDA, and other regulatory guidelines and standards.
  • To review Qualification Document examples URS, DQ, DQR, QRA, CLIA etc.
  • Responsible for Quality Management System (QMS) aspects such as Change Control (CC), Deviation, CAPA, Self-Inspection, Failure Investigation, Management Review Meeting (MRM) etc.
  • Responsible for quality system planning, implementation of cGMP in plant and maintain compliance of manufacturing activity with regulatory requirements.
  • Should be a part of the audits and keep the department under total cGMP compliance.
  • Responsible for review of executed BMR’s and BPR’s and documents related to batch release.
  • Responsible for shopfloor compliance.
  • Responsible for line clearance activities.
  • To prepare and review of the routine qualification schedule of the equipments and utilities.
  • Responsible for review of PMP and calibration planner and execution.
  • To prepare or review Standard Operating Procedure (SOP) that related QA Department.
  • To ensure the appropriate validation are done for area, equipment and process.
  • Responsible for control of documentation system.
  • Responsible for reviewing of production and other department records.
  • Responsible for review of master production records like master formula records, batch manufacturing records and batch packaging records.
  • Responsible for performing in-process checks and to collect In-process samples, Control samples, finished product samples, stability samples, validation samples etc.
  • Responsible for preparation, review and execution of miscellaneous study protocols and reporting study details i.e., Cleaned equipment hold time studies, Dirty equipment hold time studies etc.
  • Responsible for involving in risk assessment/risk management activities.

About you

  • Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Master's Degree in Science (Chemistry, Pharmaceutical Technology, Biotechnology).
  • At least 2-3 year(s) of working experience in the related field is required for this position.
  • Experience in Pharma/Manufacturing industry is desirable.
  • Fresh graduates with relevant internship experience are welcome to apply.
  • Proficient in Microsoft Office Suite.
  • Must be willing to work at Bandar Baru Enstek, Negeri Sembilan.

Job Type: Full-time

Pay: RM2,800.00 - RM3,500.00 per month

Benefits:

  • Free parking

Schedule:

  • Monday to Friday

Work Location: In person

Expected Start Date: 04/07/2025