Job Summary

1. To establish the quality system

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

2. To audit compliance to the quality system

•   Audit for compliance to policies and procedures: on paper vs. practice
•   Report on the performance of the quality system, including trends, that help
decision making for targeted actions

3. To establish procedures and specifications

•   Ensure that procedures and specifications are appropriate and followed
•   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

•   Ensure that appropriate manufacturing in-process controls are implemented
•   Ensure in-process controls are performed during manufacturing operations and results are satisfactory

5. To perform laboratory tests or examinations

•   Perform laboratory testing of components, containers, in-process materials, packaging materials and drug product using validated methods against scientifically-derived, fit-for-purpose specifications
•   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
•   Perform retests or reexamine approved components, drug product containers and closures after long storage or exposure to adverse conditions

6. To review and approve

•   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
•   Review and approve/reject reprocessing and rework procedures
•   Review and approve/reject production batch records and make the final decision to release a product lot into commerce.

7.    To ensure investigation of nonconformance

•   Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes

8. To keep management informed

•   Report on product, process and system risks—and keep management informed
•   Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure—and keep management informed
•   Keep management informed—get it?

9. To describe responsibilities in writing

•   Have a complete and compliant procedure that describes responsibilities
•   Follow the procedure

10. To remain independent

•   Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities
•   Be independent reviewer and approver with respect to manufacturing and process/ product development units

Qualification Required & Experience

•   must have 5-7 year of experience with a pharmaceutical company as a laboratory Technician.

Location: Accra

How To Apply For The Job

Contact the recruitment coordinator on:-

0302-021810

Interested applicant should send CVs to:-

jobs@thetopnotchgroup.com

Closing Date: 25 February, 2015