Associate Executive, IPQA

About us

Novugen is a wholly owned subsidiary company of a UAE-based group, SciTech International. With over 30 years of experience in the healthcare industry, the company is equipped with vast experience in venturing into strategic healthcare businesses and development of world-class healthcare facilities around the globe. We bring hard-to-source and technology intensive products to the market.

Our manufacturing facility in Bandar Enstek, Negeri Sembilan is the FIRST USFDA approved pharmaceutical manufacturing facility in Malaysia and the only in Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from API to Finished Products R&D and manufacturing.

The people behind Novugen are professionals coming from diverse backgrounds and nationalities from all over the world, working together to achieve one common goal. We strive to innovate new concepts to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity.

Our vision is to be the largest and fastest growing pharmaceutical company in Southeast Asia by 2025, competing in global markets. Through our passionate teams and continuous investment in R&D, we aim to provide early access to affordable medicine of the highest quality. This is our commitment to change lives worldwide.

Job 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

Job Requirements:

• Candidate must possess at least a Bachelor's Degree, Post Graduate Diploma, Professional Degree, Master's Degree in Science (Chemistry, Pharmaceutical Technology, Biotechnology)
• Fresh Graduate or 1 year working experience in the Pharma QA / Pharma Manufacturing, or QC environment.
• Previous experience of IPQA, supported by knowledge of In-process of Pharmacuetical Manufacturing quality standards and compliance requirements and processes, and familiarity with a variety of GxP IT systems.
• Must be willing to work in Bandar Enstek, Nilai

Job Type: Full-time

Benefits:

• Maternity leave
• Professional development

Schedule:

• Monday to Friday
• Rotational shift

Ability to commute/relocate:

• Bandar Baru Enstek: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

• Please state your notice period.
• Please state your salary expectations.

Education:

• Bachelor's (Preferred)

Expected Start Date: 01/06/2025