Hiring process continues despite current events (Covid-19)
WHAT WE ARE LOOKING FOR
Are you an experienced Professional with knowledge in a wide range of Good Manufacturing Practices & Good Laboratory Practices? Do you like leading a wide variety of projects and taking responsibility into your own hands? Do you enjoy working in dynamic cross functional teams? Do you have excellent project and time management skills, as well as an ability to communicate, negotiate and influence? If the answer to these questions is yes, then we would like to hear from you.
The scope of the position is to ensure technology and knowledge transfer from Centers of Expertize (CoE) in terms of product and process quality to the factory by reviewing and ensuring timely transition of global specifications into local specifications and ensuring that manufacturing processes are validated and suitable to comply with the expected quality level.
The main responsibilities of the person will be:
- Product Quality Performance monitoring
- Product & Process Non-conformity Management
- Batch Release Management
- Control Strategy Management
- Customer Complaints Management
- Corrective & Preventive Actions Management
- Process Validation Management
- Risk Assessment Management
- Change Management Coordination
- Define and establish validation strategy, plans and related procedures to provide guidance to project and process engineers to qualify and validate manufacturing process, equipment and utilities.
- Define and coordinate risk management approach and ensure that mitigation plans are defined, followed and implemented by SME.
- Manages relationships externally and internally.
- Builds cross-functional and cross-departmental support, fostering overall effectiveness. Ensure compliance through assisting in audits. Ensure that all validation activities are carried out and reported in a timely manner.
- Provide high-level qualification and validation expertise and support different partners that have different level of understanding and practices.
- Organize and manage the work of team members, motivate them and encourage professional and career development in order to enable them to perform all the assignments. Ensure skill matrix availability for each role, define a training path, and plan for each team member.
- Facilitates, encourage and coordinate continuous improvement concerning Product Quality and Processes.
- Support Open+ (integrated operating system) deployment.
- Lead and coordinate change Management process in the factory and ensure that the validated state of processes, methods and systems are maintained.
- Master degree in Engineering, Chemical/Biological sciences or Physical sciences
- At least 5 years experience in Quality Assurance in pharmaceutical, Medical Devices, food or similar industry.
- Experience in design control and validation activities.
- Advanced knowledge of relevant standards (ISO, ICH, GMP and GLP)
- Experience in environment working with FDA Inspections is an advantage
- Well-developed PC skills (Microsoft Project, Excel, Word, PowerPoint, Outlook)
- Fluent level of written and spoken English
- Availability to travel abroad
RISE TO THE CHALLENGE
You will join a dynamic, international and fast-paced work environment in a constantly evolving industry and will interact with different levels of experience and expertise across the Company. We offer a permanent contract with competitive salary commensurate to the professional experience.
Our company offers you a fresh perspective. Here, you will never stop exploring and discovering. We take on-the-job learning to another level, giving you every opportunity to develop your career and reach your full potential. This position will advance your experience with innovative technologies, services, and processes. Backed by a competitive salary and compensation package, you will work in a professional setting with clients and team members from all over the world.
* Reduced-Risk Products (“RRPs”) is the term we use to refer to products with the potential to reduce individual risk and population harm in comparison to smoking combustible cigarettes.
This vacancy is published internally and externally at the same time. In the event of equal suitability, internal candidates are given priority in the procedure. Please note that only online applications will be taken into consideration. Only selected candidates will be contacted.