QA Manager

  • brilliant lifesciences pvt ltd
  • Ahmedabad, Gujarat, India
  • Apr 02, 2017
Full time Manufacturing Pharmaceutical

Job Description

.    To establish the quality system

a. Establish the quality management system to describe how the firm complies
     CGMPs and operates to maintain a state of control
b. Keep current with good industry practices, and applicable to the mission of   your operation.
 
2.    To audit compliance to the quality system

a. Audit for compliance to policies and procedures: on paper vs. practice
      b. Report on the performance of the quality system, including trends, that help
      decision making for targeted actions
 
3.    To establish procedures and specifications
     a. Ensure that procedures and specifications are appropriate and followed
     b. Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.)
 
4.    To establish manufacturing controls
     a. Ensure that appropriate manufacturing in-process controls are implemented
     b. Ensure in-process controls are performed during manufacturing operations and results are satisfactory
 
To perform laboratory tests or examinations
     a.   Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications
     b. Approve or reject drug products manufactured, processed, packed, or held under contract by another company, i.e., final product release is not delegated to a contractor
     c. Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions
 
 
 
6.    To review and approve or reject all things CGMP
     a. Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications—including changes to these documents
     b. Review and approve/reject reprocessing and rework procedures
     c. Review and approve/reject production batch records and make the final decision to release a product lot into commerce.
 
7.    To ensure investigation of non-conformance
     a. Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes
     b. Review complaints to determine if it relates to a failure to meet specification, if so investigate and report to FDA if it is serious and unexpected
 
    8.    To keep management informed
          a. Report on product, process and system risks—and keep management informed
           b. Report on outcome of regulatory inspections and ensure responses are      complete and managed to verifiable closure—and keep management informed
         c. Keep management informed—get it?
 
   9.    To describe responsibilities in writing
        a. Have a complete and compliant procedure that describes responsibilities
        b. Follow the procedure
 
  10. To remain independent
        a. Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities
        b. Be independent reviewer and approver with respect to manufacturing and process/ product development units