Critical Parameter Officer - #10522365
Symbiotica Speciality Ingredients
Job Summary and Area of Responsibility:
1. Responsible for achieving quality goals.
2. Responsible for meeting production targets.
3. Responsible to maintain and implement QMS & GMP.
4. To carry out any other duty assigned by his / her superior
Major Duties and Performance Standards to be achieved:
1. Responsible to identify what process controls should be implemented upstream in order to minimize variability on critical manufacturing processes of Active Pharmaceutical Ingredients.
2. Responsible to determine which parameters are most sensitive to their requirements and allocate appropriate resources to ensure adherence.
3. Responsible to set manufacturing precision levels by ensuring that critical parameters are flowed down properly.
4. Responsible to make sure that the optimized values of the critical parameters are sustained.
5. Responsible to review and monitor the critical parameters during production-equipment design and implementation.
6. Responsible to validate the control ranges for each operating parameter.
7. Responsible to manage parameter risks in manufacturing capability.
8. Responsible to check unit-to-unit, external or environmental and deteriorative parameters.
Symbiotica Speciality Ingredients Sdn Bhd is a Technology based, Export oriented, Life Sciences company, manufacturing Active Pharmaceutical Ingredients, with a presence in over 45 countries worldwide, spanning 5 continents. We are located with our corporate office at Prai and Production facility in Kulim, Operating under cGMP guidelines and certified for ISO 9001:2015. Established since 2001, the company has won recognition awards from the Malaysian government over the years. In line with our expansion plans.