- Seremban, Negeri Sembilan Seremban Negeri Sembilan Malaysia
Lokasi Kerja
Penerangan Kerja
Tanggungjawab
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, impacting lives across the world.
Together, we are shaping the future of healthcare and changing lives everywhere.
About The Role
The Executive, Production will oversee routine manufacturing and packing activity, cost improvement, people management as well as process improvement programs. This role will based at Novugen Oncology Sdn Bhd.
Key Responsibilities:-
Responsible for ensuring daily production activities are carried out in accordance to codes of Good Manufacturing Practice (GMP) and local authorities requirement and ensure good housekeeping is practice.
Responsible to prepare and arrange tasks for the Manufacturing and/or Packaging Lines.
Responsible to operate and perform troubleshooting for Manufacturing and/or Packaging Lines in safe and efficient manner.
Participate in all aspects of product and development activities which include upgrading of product quality, process validation, equipment qualification and troubleshooting.
Responsible to prepare, revise and maintain departmental Standard Operating Procedures (SOPs) and Batch Records, including BMR and BPR in compliance with Good Documentation Practice (GDP).
Responsible for supporting quality audits (internal and external) and responding to audit reports.
Responsible for participating in investigation and preparation of reports for QMS documents compliance.
Responsible to execute and monitor manufacturing process from dispensing up to packing line.
To support production leadership to monitor and achieve yield and productivity target for manufacturing batches.
Establishes and maintains effective communication with Production and cross-functional team.
Responsible to follow Safety guidelines at the workplace.
Responsible to perform other related duties as assigned to meet departmental and company objectives.
Coordinate with CFTs like R&D, Technology Transfer, QA, QC, Engineering, Supply Chain & other departments to discuss on process or equipment related issues.
About you
Possess Bachelor’s Degree in Pharmacy / Science / Engineering / Pharmaceutical Engineering / Biotechnology / Manufacturing or any other related field.
Fluency in English, spoken and written is preferred.
More than 2 years’ related experience from Pharmaceutical or Healthcare manufacturing industries.
Has knowledge of pharma manufacturing requirements and GMP requirements.
Has relevant experience in handling process related document, QMS and troubleshooting knowledge within pharmaceutical manufacturing environement.
Peringatan Penting
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