- Perform and process in-process tests, perform other basic QA functions in raw materials, finished products and documentation when designated.
Duties (in Order of Importance)
– Receive SOP training then perform in-process QA duties in production areas.
– Substitute, when second shift personnel is absent/on leave.
– Assist to issue /review/update/maintain change control system, document review system
and document status list i.e. CCR/ECR/LCR/CMCCR/DRN.
– Assist/ update training records.
– Assist to control and maintain SOPs.
– Assist/coordinate internal audits and cGMP training schedules.
– Assist/initiate materials retest schedule.
– Assist/prepare discrepancy reports for expired/rejected materials/products.
– Assist/perform incoming material/product inspection processes.
– Assist/handle and monitor stability study samples and retention samples.
– Assist/review completed batch production records before release.
– Assist/review Quality Control test reports of API materials, packaging materials, in-process
and finished products before release.
– Assist/perform vendor qualification program and outsourced activity processes.
– Assist/follow up deviation investigation reports and CAPA processes.
– Prepare product quality review report on the parts related with their functions.
– Revise/create SOPs.
– Perform other duties, as assigned.
Requirements for Special Knowledge, Skill and Ability
– English fluency and excellent communication skills
– Detail oriented
– Have positive and professional demeanor
Minimum Requirement for Education
– Bachelor’s degree or equivalent, or
– AA degree or equivalent, plus 1 year related industry experience.
To apply for this position, please email resumes at email@example.com.