Descripción:
Our client a leading Pharmaceutical Company is currently searching for a Project Manager for their company in Danmark area, they are specialised within the Pharma industry. The Project Manager will be managing a broad spectrum of projects. You will be tasked with execution of projects, scheduling, design review, and organising project charters.
Responsibilities:
• Perform "Final Sign-off on material submissions uploaded.
• Validate that the metadata / review tier aligns with the submitted materials.
• Cross-functional team meetings: Project manages a team of 10 to 20 cross-functional team members.
• Schedule, manage and facilitate formal concept review requests, schedules live review meetings to resolve and discuss reviewer comments (i.e., Tier 1 reviews, Formal Concept Reviews).
• Creates and communicates weekly review team meeting agendas.
• Prioritize and schedule any additional live meeting requests (e.g., exceptions, revise & resubmits) as needed.
• Schedule and facilitate weekly live prioritization meetings with business owners.
• Act as a neutral facilitator in project discussions, summarizes team agreements and maintains required documentation of discussion outcomes.
• Maintain a positive, energetic, and engaged attitude and approach to workers.
Essential Skills:
• The Project Manager work with project teams at client sites to inspect, test, and troubleshoot bio-pharma manufacturing, packaging, and utility systems and equipment. This person is responsible for identifying and coordinating activities for commissioning and qualification and creating engineering and qualification protocols and reports.
• The Project Manager will also manage the resources (people and budget) for same. The • Project Manager will interact with client (Bio-pharma companies) personnel and the Regional Manager.
• Strong knowledge of GMP and regulatory requirements.
• Applied advanced and diverse engineering principles to the design and implementations of major systems, modifications.
• An individual with excellent social, time, and leadership skills
• English fluency , Danish would be an advantage
• Strong problem solver and creative thinker.
• Teamplayer.
• Pro-active thinking.
• Attention to detail
• High level of motivation and strong desire to learn
• Organizational skills and effective time management to succeed in a fast-paced environment.
• Ability to multi-task and meet or beat deadlines
• Ability to interact successfully with all levels of an organization
• Effective communication skills.
Job experience:
• Minimum 5-7years + of PM experience
• Bachelors in Engineering or Science or similar.
• Experience commissioning and qualifying bio-pharmaceutical facilities, systems, and equipment, with project management experience highly preferred.
• Experience with developing user requirements, design specifications, process/product risk assessments, validation requirements, development of testing protocols and test plans, and overall experience with the validation lifecycle is required.
• Experience with CIP/SIP, and aseptic manufacturing is desired