QA Manager / QP
Sandoz
Job Description
Major accountabilities:
Work Experience:
Major accountabilities:
- Confirm that each imported batch of medicines manufactured outside Ukraine has necessarily passed quality control in Ukraine in accordance with the current regulatory requirements of Ukraine in the field of import of medicines;
- To record in the release (sale) permit that each batch of products has been produced and/or tested/inspected in accordance with the requirements of the current legislation of Ukraine in the field of import licensing;
- Carry out incoming quality control of medicines;
- Maintain a register of incoming control of medicines;
- Authorize or reject imported medicines;
- Monitor the condition and maintenance of the premises and equipment of the Pharmacy Warehouse of Sandoz Ukraine LLC;
- Ensure appropriate validation, qualification of equipment and systems of the Pharmacy Warehouse of Sandoz Ukraine LLC, which may affect the quality of imported medicines during their storage and distribution within the responsibility of Sandoz Ukraine LLC;
- Provide the necessary training for personnel performing their duties at the Pharmacy Warehouse of Sandoz Ukraine LLC;
- Monitor the temperature conditions of storage of medicines at the Pharmacy Warehouse of Sandoz Ukraine LLC and during transportation;
- Develop, approve and update, if necessary, the documentation of the pharmaceutical quality system of Sandoz Ukraine LLC, namely standard operating procedures (import, storage and distribution of imported medicines), working instructions, as well as the Dossier of Importer.
- To control and supervise the activities of distribution service providers and the activities of the Pharmacy Warehouse of Sandoz Ukraine LLC, which may affect the quality of imported medicines, including the approval of subcontracting services, the selection and approval of such suppliers and the conclusion of quality contracts.
- Monitor and ensure the implementation of orders, requirements, orders of the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control related to medicines imported by Sandoz Ukraine LLC;
- Organize the process of withdrawal from sale and recall of medicinal products from sale, including carrying out a mock recall in accordance with the SOP of Sandoz Ukraine LLC;
- Participate in quality risk assessment, self-inspections, external and internal audits of Sandoz Ukraine LLC. Prepare, if necessary, and coordinate the implementation of corrective and preventive actions and actions to eliminate and/or minimize quality risks;
- Investigate deviations/defects/quality complaints regarding imported medicines;
- Evaluate returned/defective/recalled products and make a decision on their final placement in accordance with the SOP of Sandoz Ukraine LLC and applicable law;
- Keep appropriate protocols for the delegation of any responsibilities;
- Ensure compliance with all additional requirements of the current legislation of Ukraine regarding certain categories of products;
- Ensure proper escalation of quality incidents to the Head of the Quality Unit, and report adverse events and other special cases in the use of the Company's medicines (use by pregnant women, lack of effectiveness, improper use, etc.) to the Patient Safety Department within 24 hours from the date of receipt of such information in accordance with the Company's SOPs;
- To act as a representative of Sandoz Ukraine LLC in interaction with the state authorities of Ukraine in accordance with the current legislation of Ukraine and standard operating procedures of Sandoz Ukraine LLC, in particular within the framework of state quality control and licensing of import and wholesale trade in medicines;
- To act as a QA Manager Deputy, who is entrusted with the duties of the Qualified Person for Import and the Authorized Person on Distribution in case of his absence;
- Pass trainings on the company's internal procedures.
- Provide constant regular access to e-mail, constant communication by mobile phone.
- Perform other duties arising from the functions of the QA Manager, who is entrusted with the duties of the Qualified Person on Import and Authorized Person on Distribution and other instructions of the immediate supervisor.
- Local GMP/GDP Quality System in place and continuously updated, as required -GMP/GDP risks proactively identified and effectively mitigated.
Work Experience:
- Participating in volunteer / community projects.
- Functional Breadth.
- Collaborating across boundaries.
- Operations Management and Execution.
- Change Control.
- Continuous Learning.
- Dealing With Ambiguity.
- Guideline.
- Product Release.
- QA (Quality Assurance).
- Quality Management.
- Regulation.
- Risk Management.
- Self-Awareness.
- Technological Expertise.
- English.
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