Job Description
● Assist in setting up a quality management system and building a quality culture in the company and promoting it to the contract manufacturers and other vendors.
● Write and revise GXP documents by a collaboration of other departments such as quality manual, master plans, sops, working instructions, forms, checklists, protocols, reports, masterbatch records, etc.
● Review of batch records.
● Participation in audits and self-inspections.
● Deviation, change, and quality events managements (such as SPC and trending, APQRS, risk management, validation plans, complaints, and recall management…).
● Audits and self-inspection.
● Quality agreements.
● Deviations management (Investigation, root cause analysis, CAPAs,…).
● Change control.
● Quality events management (Non-deviation and non-change e.g. risk master plan and risk management, APQR.
● Documentation control (Formats, version control, archiving, document life cycle,...)
● Batch records master preparation and reviews.
● Manufacturing QA supervision.
● Validation and validation master plan (Scale-up/tech transfer, process validation, continuous process validation, qualifications, etc.).
● Recalls and mock recall.
