QC Analyst I

ABOUT THE JOB

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

JOB PURPOSE

Carry out QC analysis in compliance with Laboratory and analytical test methods ensuring quality, cGMP, Health, Safety and environmental standards are met. Assist in other functions such as documentation, preparation of standard operating procedures and equipment troubleshooting.

REPORTING RELATIONSHIP

The job holder reports to the QC Supervisor - Operations.

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• Participate in the Daily Capacity Management and +QDCI Level 1 sessions to ensure that site and department KPI's are met.
  
• Carry out analytical testing for Finished Product, Intermediates, Raw Material, In-Process Control and stability in compliance with specifications, analytical test methods, laboratory methods and pharmacopoeia requirements.
  
• Prepare reagents and solutions in compliance with GLP and laboratory SOP requirements.
  
• Planning and assurance of cGMP compliant quality testing and documentation according to schedule. Ensure that analyses are carried out and reported in accordance with GLP (Good Laboratory Practices, completed on time and are consistent with the business requirements.
  
• Perform analytical results review and audit trail review.
  
• Assist in carrying out maintenance of laboratory equipment in compliance with established schedules.
  
• Assist in carrying out on-the-job training for General Analytical Method to QC, by incorporating cGMP and safety aspects of the procedures.
  
• Ensure GMP documents e.g. specifications, lab methods, standard operating procedures and other GMP documents (i.e. raw data, logbooks) in the laboratory are well maintained.
  
• Responsible for electronic raw data handling in compliance with regulations and guidelines.
  
• Participate actively in efficiency management of the laboratory and contribute towards continuous improvement through teamwork, feedback and collaboration.
  
• Participate in regulatory inspection and customer audits preparedness at site with regards to cGMP Quality and HSE aspects.
  
• Ensure compliance with HSE and quality policies and site procedures. Ensure safe working in the laboratory by practicing and communicating safety. Bring out unsafe conditions and acts / procedures.
  
• Play a pro-active role in ensuring the HSE standards & Life Savings Rule are adhered to.
  
• Embrace Zero Incident Mindset and adopt the responsible of HSE protection policies and Life Saving Rules (LSR). Practice safe laboratory operations and ensure all HSE procedures are followed.
  
• Other responsibilities that are not included in the above but are related to quality control and in accordance with internal guidelines and SOP.
  

• A Diploma in Chemistry or any other related scientific discipline with minimum 3 years' experience in pharmaceutical industry.; or A fresh graduate from Degree in Chemistry or any other related scientific discipline.
  
• Must be analytical, methodical, quality conscious and a good team player.
  
• Knowledge of FDA regulations and cGMP will be desirable.