QUALITY & PV COORDINATOR – GDP RESPONSIBLE Pharmacist-DOH/MOH Valid License
at Galderma - United Arab Emirates in
Job highlightsPosted on March 22, 2021
· Coordinate and support activities related to Quality Assurance and Pharmacovigilance in the Middle East.
· Maintain the local Quality Management System and monitor its compliance status
· Contribute proactively as an effective member of the quality and PV team, functioning responsibly and autonomously while working within the framework of internal and external regulatory guidelines and procedures.
· Act as GSDP responsible Pharmacist as per MOH UAE requirements.
· Designated as Responsible Pharmacist for GS&DP License for the warehouse and ensure Good Distribution Practice (GDP) is complied with for products imported within the local distribution centre and participate in periodic review and meeting with DC.
· Perform Quality and compliance specific tasks including but not limited to processing product complaints, review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and Mock recall activities and product recall coordination.
· Perform Pharmacovigilance specific tasks including but not limited to processing spontaneous reports of adverse, Literature monitoring, aggregates reports administrations and submission according to national regulations and other PV activities as required like data reconciliation, signal alerts and archiving, update on the safety agreements and preparation for internal audits or Health authority inspections.
· Coordination to provide the global PV team with updates in the local requirements related to periodic reporting and required format and covered period to support preparation of the global PV calendar.
· Support in Implementing and maintaining the QMS to ensure that required processes are established and effective
· Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs
· Being part of the process related to quality systems such as, but not limited to; internal audits/self-inspection, change control, management reviews, deviation management and CAPA
· Compile and update training manuals plan & implement annual training. assist in preparation of induction and refresher training related to QMS for local affiliate staff and ensure that all new personnel are trained in Pharmacovigilance according to their job description.
· Ensure quality and Safety agreements are established with affiliate 3rd parties
· Ensure affiliate 3rd parties are qualified and maintained in an approved audit status
· Ensure product samples are authorized with maintained traceability and product integrity and participate in the process of sampling reconciliation as needed.
· Have an insight and support the decision related to shipments, as release or products, temp excursion, local analysis needs if any,
· Maintenance, analysis and reporting of Quality and Vigilance KPIs as per the set deadlines by corporate.
· Ensure local repackaging of products is performed in accordance with specifications and required licenses
· Develop and manage effective working relationships with competent authority and Galderma Global colleagues
· Foster and maintain good cross-functional working relationships with other departments; attend cross-functional meetings and represent the Affiliate where necessary
· Handle additional tasks that may arise according to business needs apart from QA and PV to support registrations activities.
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