Supply Chain Vacancy At Viatris Egypt
Supply Chain Quality Senior Associate
ROLE DESCRIPTION AND MAIN RESPONSIBILITIES
Maintenance of the compliance to the local BOH regulations
- Coordinate the product quality and compliance activities at the AFFILIATEs, to ensure current BOH expectations are met.
- Act as the Qualified/responsible Person to local authorities or support Qualified Person activities for all Viatris Product Quality Compliance issues in the market.
Governance & internal organization
- Responsible for the timely implementation of all applicable Global Procedures within the AFFILIATE.
- Ensure SCQs and all relevant AFFILIATE colleagues are appropriately trained in the Product Quality SOPs.
- Conduct quality management and metrics review with relevant stakeholders.
- Conduct/Oversee completion of internal assessments to ensure compliance with product quality systems and processes and to identify improvement opportunities.
- Assess new or proposed quality system/local regulatory requirements and adjust/enhance local systems and processes when required.
Training
- Support the implementation of all elements of SCQ Training systems in AFFILIATE, including implementation and refresher training on GDP/GMP to applicable AFFILIATE colleagues.
- Ensure that all assigned Viatris trainings (My University for example) are completed in timely manner.
- Participate in regular meetings with relevant AFFILIATE stakeholders.
Change Controls
- Organize and prepare planned, permanent, and temporary changes of GMP/ GDP related activities and systems in the AFFILIATE.
- Participate and or organize change’s committee as appropriate and ensure the required approvals.
- Ensure change actions completion as per the agreed timelines.
Inspection and Internal Audit
- Participate in preparation and coordination of GMP/GCP/GDP/MAH related inspections of AFFILIATE Viatris internal/Global audits
- Work with SCQ Sr Manager/ TL and local functions to Prepare an appropriate action plan to address the inspection/audit observation.
- Responsible for implementing and tracking the commitments/identified actions within agreed timelines.
- Internal self-inspection process management:
- Setting the SI plan according to local needs and priorities
- Ensure the timely implementation of the self-inspection plan as per the assigned tasks as auditee and / or auditor.
Notification to Management
- Notifies SCQ Head of Quality of significant product quality and compliance issues.
- Attend CQN meetings, as AFFILIATE representative, to provide the local perspective on the issue at hand.
- Provide CQN Executive Summary including local investigation results and proposed CAPAs for issues originating under the responsibility of the AFFILIATE.
- Ensure the local implementation of actions identified during CQN meetings e.g. recalls, communication with Regulatory Agency, local CAPAs and provides feedback on progress
Deviation and CAPA Management
- Perform investigation of product quality incidents that occur within the responsibility of Viatris country office in cooperation with the relevant internal/external functions.
- Track the preventive and corrective actions until completion within the set due dates.
Product Complaint Handling (if applicable for Country)
Scenario 1: responsible for handling product quality complaints
- Manage the intake and triage of complaints from the markets under AFFILIATE responsibility, assign class and criticality to the product complaint and forwards them to the appropriate investigating VGS/Contractor manufacturing site via the global complaints management system (Trackwise)
- Develops and issues responses to complainants in a timely manner.
Scenario 2: : responsible for overseeing the handling of product quality complaints
- Oversee correct prioritization, categorization and timely reporting of products quality complaints originating in the local market and ensure compliance with applicable local regulations and Global Procedures via the global complaints management system.
- Ensure correct prioritization, categorization and timely reporting of products quality complaints
Local Product Disposition
- Responsible to Review all documents and records relevant to the imported products and perform the necessary activities to provide a disposition decision to the products to the market sale in compliance with local regulatory requirements and Viatris procedures.
Quality Oversight of local repackaging/relabeling operations
- Ensure relabeling/repackaging contractors have been assessed and approved
- Ensure local regulatory authorities’ approval of the repackaging/relabeling activities
- Ensure all needed Viatris approvals are completed and escalate packaging requests for regional lead approval
- Ensure SCQs release of the repackaged/relabeled product according to the GSP/PQS and local requirements
- Notify Sr manager of deviations or concerns occurred/noted during repackaging/relabeling operations and any issues with the potential to impact marketed product
Market Returns
- Responsible to define requirements under which returns can be taken back to saleable stock and supports local actions in cooperation with Logistics and Distribution Centers.
- Assess the returned goods and provide a disposition decision if applicable
Quarantine Alert Notices
- Receive and manage Quarantine Alert Notices (QAN) issued by Viatris manufacturing site, Contractor manufacturing site or distribution center.
- Ensure status of impacted batches at logistics center/LSP/contract vendor is changed to Blocked/Hold and then aligned with final disposition decided by QAN issuing site
- Provide the required responses to QAN issuing site on timely manner.
Market Action
- Attends, as needed (as backup for example) , Critial Quality Notifications (CQN) meetings, as principal AFFILIATE representative, to provide the local perspective on the issue at hand.
- Supports to provide the local perspective on the issue and draft CQN Executive Summary for issues originating under the responsibility of the AFFILIATE.
- Implements the local actions identified during Area Quality Review Team (CQN) meetings, e.g., recalls, communication with Regulatory Agency, local corrective/preventive actions.
LSP / Contractor management & oversight
- Oversee quality operations at contractors or provide feedback to the appropriate functions
- coordinate, support and participate in Global Operations Audit (GOA) audits
- Agree with contractors/LSPs on action plans to address observations noted during the audits or regular visits Document and track all CAPA plans.
- Notify SCQ Manager of significant concerns or repeated deviations that occurred with contractors and all issues potentially affecting marketed product.
Viatris Egypt Distribution Center Oversight
Viatris Distribution center is responsible for storage, transportation & distribution of Viatris Finished Goods. Quality Oversight of distribution center is significant for ensuring maintaining GxP & regulatory expectations.
SCQ responsibilities include but is not limited to the below:
1- Quality Induction Training
2- Quality Oversight on warehouses
3- Development of local SOPs
4- Oversight over operational activities including storage, transportation, overprinting activities.
5- Endorsing all GxP activities at DC including, personnel, Training ;etc.
Quality agreements
- Develop, negotiate and maintain up to date quality agreements with all affiliate GMP/GDP contractors involved in manufacturing, repackaging, laboratory testing or activities at LSPs
Qualifications/Skills
Years of experience 0-3 years in the Pharmaceutical or related regulated industry.
Technical skills
- Possesses relevant education in science or quality-related topics, such as a bachelor’s degree, pharmacist, or Engineer.
- Demonstrates comprehensive knowledge of quality principles, concepts, and technical expertise.
- Capable of working and contributing effectively in cross-functional teams, navigating cultural differences and diversity.
- Able to make sound and effective quality decisions.
- Fluent in the English language.
- French
Soft skills/ management
- Self-motivated, confident with working independently, motivate others, Business acumen.
- Act decisively and take strategic decisions.
- Grow self.
- Hold People accountable.
- Change agile.
- High self-awareness.
- Influence others.
- Emotional intelligence skills and Knowledge.