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Senior Project Leader – Healthcare Product Expert
Il y a 3 mois
We are seeking a seasoned Engineer or Pharmacist with a minimum of six years of experience in the healthcare sector, particularly interested in the consulting field and the multifaceted challenges it presents.
As a Project Manager at AKTEHOM, you will provide support to clients across the healthcare spectrum, from large pharmaceutical companies to emerging startups, and across various product types, including injectables, solid forms, and medical devices.
Your daily responsibilities will include managing multiple client projects simultaneously. You will collaborate with diverse AKTEHOM project teams composed of specialists with complementary expertise to effectively tackle client challenges. These projects will vary in nature, necessitating both strategic planning and hands-on execution (including coordination, project oversight, and 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 expertise will encompass:
- Product/Process Expertise: Implementation of Quality by Design (QbD), conducting characterization studies, and optimizing processes.
- Process Validation: Conducting risk assessments, developing Control Strategies, and overseeing process validation and transfer.
- Contamination Control: Managing cleaning processes, decontamination, sterilization, and evaluating extractables and leachables.
- Quality Systems: Engaging in risk management, process control, supplier oversight, data management, and ensuring data integrity.
- Commissioning & Qualification: Overseeing equipment, facilities, utilities, and validation of systems.
- Regulatory Compliance: Monitoring and interpreting regulations, assessing compliance, and providing support for regulatory inquiries.
- Analytical Techniques: Validating and transferring analytical methods, and implementing analytical QbD.
- Human and Organizational Development: Providing training, supporting change management, and offering technical and interpersonal coaching.
The ideal candidate will possess:
- A comprehensive understanding of healthcare operations and various roles within the industry.
- Expertise in relevant quality and regulatory standards.
- Proficient English communication skills for leading discussions and creating deliverables for international clients.
Strong customer service abilities, combined with a broad, interdisciplinary perspective, will enable you to build trusted relationships with clients and colleagues.
If you are enthusiastic about contributing to a dynamic organization and thrive on challenges, we encourage you to consider this opportunity.
This position is inclusive and welcomes applications from individuals with disabilities or similar qualifications, as outlined by labor regulations. AKTEHOM is dedicated to promoting diversity, gender equality, and the employment of individuals with disabilities.
