The Clinical Pharmacy Liaison is responsible for ensuring quality oversight throughout the production process. Involved in day-to-day documentation and change control processes. Ensuring compliance in all GMP areas including but not limited to document control, change control and auditing program
Job Tasks and Responsibilities
Quality Assurance support for production operations. Responsibilities include, but are not limited to the following:
Initial review of batch records prior to QA Disposition
Co-owner of visual inspection system. Work within production on the review/approval of visual inspection yields and qualify visual inspectors.
Ensure qualifications and training of personnel in production.
Review and provide QA/QC approval to records for Sterilization/Depyrogenation, Cleaning and Sanitization, pre-weigh, and all associated forms within a batch record.
Act as Program Lead of labeling. Ensure all labels are ordered and are QA approved. Provide oversight on labeling operations, approve production labeling forms, and perform labeling AQL's
Education and Experience
AS or BS, microbiology preferred
1-3 years QA experience working in a cGMP Drug Manufacturing environment or sterile pharmacy compounding
Knowledge of relevant regulatory requirements
EM certification preferred
Strong computer skills including Microsoft Office and databases