Quality Manager
Henkel
Total des années d'expérience :5 years, 5 Mois
Job Purpose
Head of the quality department and member of the leadership team, responsible for managing the local quality department within the powder plant of Henkel Algeria .
Job Responsibilities
• People management: Management of a laboratory responsible and 10 QC technicians (i.e.. Training needs, performance monitoring, Talent development etc...).
• KPI monitoring, Quality culture deployment, team coaching.
• Driving the Quality strategy and targets in line with the Global SHEQ policy.
• Ensuring that the production activity is conducted according to Henkel’s standards.
• Defining, reviewing, updating and continuously improving the local quality management system in compliance with Henkel SHEQ strategy and Integrated Management system.
• Ensuring the implementation of Henkel inspection plans and test methods to perform quality control activities.
• Leading internal audits to maintain the following certificates: ISO9001, ISO14001, ISO 50001.
• External lead auditor for Henkel’s suppliers (i.e.: Primary material and Packaging).
• Managing deviations and complaints (Approving investigations, risk assessments, CAPAs) .
• Supporting the production during plant trials, process validation, and first production to ensure the design of new products is right first time (i.e.: Change control, Deviation, CAPAs etc...) .
• Owner of the overall local quality documentation (Author and Final approver).
• Owner of the GEMBA Walk (CAPAS follow-up, etc...)
• Driving Periodic quality reviews with local management team and reporting to regional and global quality team.
Job Purpose
Support the Quality department with the implementation and maintenance of the Annual Country Quality Plan as well as the local QMS related to the GMP/GDP activities led by the country organisation (Novartis Pharma and Sandoz SPA)
Job Responsibilities
• Ensuring that the Novartis GDP/GMP/GDocP and SOPs requirements are met in the Distribution Centre (i.e., For: Product reception, storage, and distribution, Labelling operations, Facilities maintenance, Warehouse qualification and monitoring).
• Releasing products imported by Sandoz SPA and PCH (Global CoAs, CoCs & CoBRs review, Price labels approval, Transport temperature reading, Batch records review and close out)
• Handling of: Technical complaints, Deviations, Quality events, Incident escalations on TW or 1QEM (i.e., Reporting, Recording, Investigating, Risk Assessment, CAPA plan).
• Qualification and oversight of third parties leading GxP activities (Change control, On-site assessment, Quality risk assessment, Quality agreements, KQI’s follow-up).
• Leading the local self-inspection (internal inspection) of the Country organisation and carrying out on- site assessments for external GxP suppliers.
• Assisting the Quality department in the recall process and mock recall.
• Creating, approving, and updating on ESOPS-D2: SOPs/Forms based on the local QMS.
• Building, assigning, and updating training curriculums for the Novartis associates via UP4G (i.e., Onboarding trainings, Work-related procedures, Virtual trainings etc...).
• Making sure all personnel performing GxP activities are trained and qualified.
• Participating in the quarterly and annual Quality Management Review by giving insights as to quality matters/trends.
Job Purpose
Support the Quality Assurance department to achieve the quality strategy set for GMP activities to ensure compliance, safety, and effectiveness of products throughout the stages of production within the manufacturing unit of Pharmalliance
Job Responsibilities
• Enforcing GMP/GDocP, data integrity in the production area through regular inspections.
• Ensuring that the manufacturing/packaging activities and manual operations (Segregation, labelling) are conducted in compliance with GMPs and the QMS.
• Recording, Reviewing, approving, and Closing out GxP documents (i.e., Production batch records, Forms, Logbooks, Labels, excel sheets).
• Managing deviations by investigating (RCA) and implementing a CAPA plan.
• Monitoring Verifying and approving the quality, conformity, and the quantity while goods reception (i.e., Drug substances, Bulk productsthe temperature, pressure, and humidity of the production area. •, FDF products, Packaging materials).
• Validating the cleaning operation of all assets (i.e., Equipments, Production rooms).
• Allowing the launch of the production operation (i.e., Manufacturing and Packaging).
• Support the production staff by instructing them upon GMP and GDocP.
Design of a plate heat exchanger and optimisation of the CIP process.
Familiarising with dairy manufacturing process as well as quality control analysis.
Familiarising with semolina and flour manufacturing process as well as quality control analysis.