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, and preparation of standard operating procedures.

REPORTING RELATIONSHIP

The job holder reports to the QC Supervisor – Operations.

KEY ACCOUNTABILITIES

  • Assist in carrying out on-the-job training to other QC analysts, by incorporating cGMP and safety aspects of the procedures.

  • 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 (if required) in compliance with specifications, analytical test methods, laboratory methods and pharmacopoeia requirements.

  • Ensure that analyses are carried out on time and are consistent with the business requirements.

  • Assist in carrying out maintenance / calibration records of laboratory instruments / equipment in compliance with established schedules.

  • Assist in improving and maintaining test methods and equipment (i.e. qualification, validation and transfer).

  • Prepare reagents and solutions in compliance with GLP and laboratory SOP requirements.

  • Participate actively in efficiency management of the laboratory and contribute towards continuous improvement through teamwork, feedback and collaboration.

  • Planning and assurance of cGMP compliant quality testing and documentation according to schedule.

  • Maintenance of specifications, lab methods, standard operating procedures and other GMP documents in the lab.

  • Maintenance and development of all required laboratory documents (i.e. raw data sheets, logbooks).

  • Responsible for electronic raw data handling in compliance with regulations and guidelines.

  • Participate in regulatory inspection and customer audits preparedness at site with regards to cGMP Quality and EHS aspects.

  • Ensure compliance with HSE and quality policies and site procedures. Ensure safe working in the laboratory by practicing and communicating safety.

  • Other responsibilities that are not included in the above but are related to quality control and in accordance to internal guidelines and SOP

CONTACT WITH OTHERS

  • Internal

  • Local and corporate colleagues

  • External

  • Suppliers/Vendors

  • Waste disposal contactor

JOB KNOWLEDGE

  • Diploma in Chemical Process Technology / Bio-Process Technology’ with minimum 3 years’ experience; of GCE ‘A’/’O’ level with minimum of 5 years relevant experience.

  • Must be analytical, methodical and quality conscious.

  • Knowledge of FDA regulations and cGMP will be desirable