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Project Management Specialist – Product and Process Consultant
Il y a 3 mois
Senior Engineer or Pharmacist with a minimum of six years in the healthcare sector, passionate about consulting and the multifaceted challenges it presents.
As a Project Manager at AKTEHOM, you will collaborate with clients across the healthcare spectrum, from large pharmaceutical companies to innovative start-ups, addressing a variety of products including injectables, solid forms, and medical devices.
Your daily responsibilities will include managing multiple client projects simultaneously. You will be integrated into various AKTEHOM project teams composed of specialists with diverse expertise to effectively tackle client challenges. These projects will require both strategic planning and hands-on execution (coordination, project oversight, on-site assistance).
You will take the lead on projects, ensuring both the technical and interpersonal success of each initiative, while fostering client relationships and enhancing AKTEHOM's capabilities.
Your key areas of proficiency include:
- Product/Process Expertise: Implementation of Quality by Design (QbD), characterization assessments, process enhancement...
- Process Validation: Risk evaluation, Control Strategy development, validation processes, transfer protocols, monitoring activities
- Contamination Management: Cleaning protocols, decontamination procedures, sterilization techniques, extractables and leachables assessments...
- Quality Management Systems: Risk assessment, process oversight, supplier evaluation, data governance, data integrity
- Commissioning & Qualification: Equipment, facilities, utilities, and validation systems...
- Regulatory Compliance: Monitoring and interpreting regulations, compliance evaluations, support for regulatory inquiries
- Analytical Techniques: Validation and transfer of analytical methods, analytical QbD
- Human and Organizational Development: Training initiatives, change management facilitation, technical and interpersonal coaching
As a Senior Engineer or Pharmacist with extensive experience in the healthcare industry, you will have a comprehensive understanding of the operational dynamics within healthcare organizations and a solid grasp of various roles.
Your background will equip you with:
- A holistic perspective on healthcare operations and a solid understanding of diverse roles
- Mastery of relevant quality and regulatory standards
- Proficient English communication skills for leading discussions and creating deliverables for international clients.
Strong customer service capabilities, combined with a broad, interdisciplinary outlook, will enable you to build trusted partnerships with clients and your team.
You are motivated to contribute to a dynamic organization and embrace challenges.
This position is inclusive and welcomes applications from individuals with disabilities or similar, as outlined by labor regulations. AKTEHOM is dedicated to promoting diversity, gender equality, and the employment of individuals with disabilities.
