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QA Operations Lead 

Job Purpose: 

The Quality Assurance Operations Lead is responsible for ensuring compliance of production processes, quality control, and other related activities with regulatory standards and internal quality requirements. Work closely with production, maintenance, supply chain (SC), and quality control (QC) teams to ensure the integrity of products throughout their lifecycle. They are also tasked with reviewing batch records, preparing release documents, and managing change requests, as well as investigations related to deviations and complaints, and corrective actions. 

Key Tasks:

• Ensure Compliance: Ensure that all production processes adhere to Good Manufacturing Practices (GMP), HACCP requirements and current regulations and are aligned with the validated processes.
• Monitor the implementation of Quality Management Systems (QMS) related to the responsibilities of the position.
• Record Review: Review batch records for both local and CMO products and prepare release documents.
• Verification: Verify analysis reports of finished products and records of production measurement instruments.
• Non-Conformity Management: Analyze quality discrepancies, manage deviations, CAPA (Corrective and Preventive Actions), and production investigations related to OOS (Out of Specification).
• Decision Making: Actively make decisions about quality topics raised during the manufacturing of the finished products.
• Continuous Improvement: Propose and implement continuous improvement initiatives to optimize production processes and ensure product quality.
• Audits and Inspections: Participate in internal audits as well as regulatory inspections and prepare the necessary documentation.
• Training: Train production staff on quality procedures, GMP reminders, and regulatory requirements. KPI
• Monitoring: Monitor key performance indicators (KPIs) related to the responsibilities of the position.
• Risk Management: Develop and manage applicable risk assessments on site. Certification: Monitor Halal and HACCP certification and participate in GMP quality audits.
• Quality Transactions: Perform quality transactions in the SAP QM module for finished products (FP), raw materials (RM), and packaging materials (PM).
• Preparation of COCs: Prepare Certificates of Compliance (COC) export products and as needed.
• Backup for QA Head: Serve as the Secondary backup for the QA head. 

Key Working Relation: Work closely with production, maintenance, supply chain (SC), and quality control (QC) teams 

Skills & Qualifications:

• Rigor and attention to detail.
• Ability to analyze data and make fact-based decisions.
• Organizational skills and the ability to manage multiple priorities simultaneously.
• Proactivity and the ability to work independently.
• Capacity to learn new techniques and perform multiple tasks concurrently.
• Qualifications: Degree in Life Sciences, Chemistry, Applied Biology to Bio-Industries, or equivalent.
• Over 5 years of experience in a similar role and 10 years in the quality department within the pharmaceutical industry.
• In-depth knowledge of Good Manufacturing Practices (GMP) and pharmaceutical regulations. Project management and problem-solving skills.
• Excellent communication skills, with proficiency in French and English. Ability to work in a team and collaborate with various departments (Engineering, Production, Supply Chain, QC, QA).
• Proficiency in computer tools and quality management systems, including SAP.

DSO Behaviors:

• Customer Focus: Prioritize the needs and expectations of internal and external customers in all quality assurance activities.
• Accountability: Take ownership of quality outcomes and be responsible for the decisions made regarding compliance and process integrity.
• Collaboration: Foster strong relationships with cross-functional teams to enhance quality assurance processes and ensure a cohesive approach to product integrity. 
  Adaptability: Be open to change and able to adjust strategies and approaches based on evolving quality standards and industry regulations.
• Continuous Learning: Commit to ongoing professional development and staying informed about the latest trends and best practices in quality assurance

Location:

Morocco : Casablanca-Settat : Casablanca / Aéoropole  

Division:

Consumer Health 

Reference Code:

862343 

You can contact us here: 
https://www.bayer.com/fr/ma/afrique-du-nord-contact