Develop standard operating procedures (general quality and departmental) to ensure that the steps are collected in each case and comply with internal and external regulations applicable in each case.
Review and approved internal SOPs
Document management, distribution of authorized copies and removal of obsolete copies.
Manage Change Controls, CAPAs and complaints.
Manage discrepancies, root cause analysis, management layers and trend analysis.
Provide initial GMP training program compliance.
Validation activities related to manufacturing and cleaning processes
Participate in the approval and certification of suppliers, auditing suppliers of raw materials and material conditioning.