Assistant Quality Assurance at Sphinx Pharmaceutical

Job Summary

Responsible for  all Quality Assurance Activities in order  to meet agreed organizational performance goals within agreed budgets and timescales (covering relevant areas GMP, GLP, GDP , and whatever else falls within limit according to Quality goals and objectives of Sphinx Pharmaceuticals Limited)

Responsibilities

The Assistant Quality Assurance shall ensure

• Pharmaceutical products are designed and developed in a way that takes account of the requirements of GMP and other associated codes such as those of Good Laboratory Practices (GLP) and Good Clinical Practice (GCP).
• Production and control operations are clearly specified in a written form and GMP requirements are adopted.
• Arrangements are made for the manufacture, supply and use of the correct starting and packaging materials;
• All necessary controls on starting materials, intermediate products and bulk products and other in-process controls, calibrations and validations are carried out.
• The finished product is correctly processed and checked, according to the defined procedures.
• Pharmaceutical products are not sold or supplied before the authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the marketing authorization and any other regulations relevant to the production, control registration, legislation and release of pharmaceutical products according to the Licensing Authority.
• Satisfactory arrangements exist to ensure, as far as possible, that the pharmaceutical products are stored by the manufacturer, distributed and subsequently handled so that quality is maintained throughout their shelf-life.
• There is a procedure for self-inspection and quality audit that regularly appraises the effectiveness and applicability of the quality assurance system.
• Validations and Qualifications
• Risk assessment and evaluation
• Any other duties as assigned by the Quality Assurance Manager.

Qualifications

• A bachelor of pharmacy degree or a Bachelor of Science degree in either analytical chemistry, Biochemistry, organic chemistry, pharmaceutical chemistry, chemical engineering or microbiology from a recognized university.
• Additional training in management will be an advantage.
• Ability to work independently and as part of a Quality Assurance team is desired.
• Experience of a minimum of two (2) years in a similar position or 5 years in a Quality Control Laboratory supervisory position is a must.