Quality Consultant
1 week ago
RESPONSIBILITIES - PRIMARY DUTIES
- To monitor and ensure that all Company Policies and Procedures are followed by World Courier the assigned country.
- To follow Quality Assurance Policies and Procedures, interpreting and implementing Quality Assurance Standards.
- To coordinate the actions to be taken with other QA representatives belonging to Incountry Quality department.
- Ensuring and improving the quality of the service provided to the clients by working close to the operational team.
- To participate in the CAPA and complaint process, including reporting to global QA any deviations or potential problems, participate in the investigation, support with the generation of reports, and tracking deviations and actions as described on the specific internal guidelines.
- Responsible for coordinating all internal and external audits and regulatory inspections (ISO 9001, ISO 14001, GDP and Client) and coordinating all audit replies.
- Responsible for preparing all required documents and information to present during External audits and ensuring that a World Courier Confidentiality Agreement has been signed.
- Responsible for quality related activities included but not limited to CDA and Quality Agreements. Responsible for reviewing Local Standard Operating Procedures (SOPs) and Work Instructions (WI) to ensure the service standard and qualities are met.
- Establish appropriate training material and conduct training for general quality topics.
- Assist in setting up and to participate in Risk Management and Change Control processes.
- Enter all local relevant data into QA SharePoint to allow for timely quality metric generation.
- Assist the country in ensuring compliance to World Courier and country specific documentation / retention requirements.
- Serve to assist as first line contact in order to inform the company about regulatory updates that might impact World Courier service.
- Overview calibration, maintenance and qualification program according to internal guidelines, supporting the local facility representative and QA manager technical compliance.
- To identify along with local team, the need of local procedures and implement Local internal guidelines in accordance with operational and technical needs and local regulations, respectively.
- Responsible for quality related activities related to the Self-Inspection Report. (Transport)
- To review the information on the temperature periodic report for all temperature controlled areas. (Transport)
- To support any changes/developments initiated by the Regional /Global Quality Management.
- Any other quality responsibilities assigned by Regional/Global Quality Management.
- Detailed knowledge of World Courier's Satellite Storage Location (SSL) service operations. (MEL and transport) Knowledge of good practices in line with the SSL service. (MEL and Transport)
- Assure that World Courier Depot License(s) as well any other regulatory documentation is/are properly in place and updated. (CSS )
- To contact clients whenever required in order to communicate expansions, depot moving process, regulatory updates clarifications, etc. (CSS)
- To overview that cleaning program is properly implemented and documented. (CSS)
- Communicate to Management team and QA Department, along with Depot and /or Warehouse Manager and Depot Pharmacist, exceptional needs for the storage of products required by clients/ sponsors.
- To provide local regulation background to support Management and QA team decisions.
- To conduct Quality checks and release for GMPrelated materials for secondary repacking activities. To ensure that this task is properly arranged / delegated to a backup Quality personnel in the event of absence. (CSS)
Packaging / Labelling:
To conduct and document quality checks for secondary repacking activities.
- To review the completeness of the batch packaging records and ensure all data are filled in in accordance with World Courier's Good Documentation Practices procedure.
- To review and approve the repacked products to the client for client's final release and disposition.
- To ensure that QA tasks related to repackaging activities are properly arranged / delegated to a backup Quality personnel in the event of absence.
- Ensure that physical batch packaging records are retained and archived. (CSS)
- Perform spot checks (as described in WC internal guidelines) to other operative activities in order to monitor that WC procedures and protocol/program instructions are properly performed by depot staff. (CSS)
- To support recalls and mock recalls conducted in the Depot In accordance with applicable internal guidelines. (CSS) To act as witness during the destruction process fo
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