The Director of Quality Assurance (QA) directs, monitors and facilitates all QA activities. Quality Assurance may be defined as actions, planned and performed, to provide confidence that all systems and elements that influence the quality of the product are working as expected. Position has authority to stop production when warranted. QA Coordinator position performs function as a back-up.
Essential Job Functions:
·Ensures review and approval of all SOPs is performed in a manner to ensure compliance with all applicable statutory and regulatory requirements prior to implementation.
- ·Ensure QA Unit maintains an index of all SOPs, master documents and archived obsolete SOPs
- ·Ensuring SOP content is reviewed to assess impact on other systems and their functions
- ·Ensuring each employee is provided with, and has on-going access to SOPs to perform assigned duties
- ·Ensuring validation protocols are designed prospectively, performed and evaluated and written validation reports are prepared.
- ·Ensuring modifications or changes in SOPs are appropriately documented including the rationale for change. Changes in SOPs are to be made in accordance with a written procedure and be formally approved before implementation
- ·Ensuring SOPs for all QA Unit activities exist and define the QA Unit’s responsibility for performing SOP review, approval, or authorization
- ·Ensuring a method exists to promptly update pertinent SOPs to reflect changes in manufacturer’s directions for use and that all SOPs and manufacturing records are reviewed at least annually.
- · Assist in developing, reviewing, and ensuring the approval of training and educational programs for all personnel.
- · Review and evaluate PT results with the Lead and Director to identify trends and specific problems
- · Ensure adequate validation procedures have been performed
- · Identifies need for re-validation or revision of validation procedures
- ·Ensure procedures are established and followed to review, evaluate, investigate, and correct manufacturing deviations
- ·Ensures a system to ensure timely reporting of deviations that may affect the safety, purity, identity, or quality
- ·Ensures required records are reviewed as necessary to ensure the accounts and complete history of all work performed
- ·Ensures records are reviewed for accuracy, completeness, and compliance
- ·Ensures product QC failure is investigated
- ·Performs or delegates quality audits of operating systems on a routine and/or focused basis
- ·Ensures procedure exists for responsible head and Medical Director to review audit report