Project Manager - Quality Computer Systems

Descrizione del lavoro:

Company Description:

(COMPANY NAME) Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, (COMPANY NAME) works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. (COMPANY NAME) believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, (COMPANY NAME) has grown from one laboratory in Nantes, France to over 48,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. (COMPANY NAME) offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, (COMPANY NAME) generated total revenues of EUR EUR 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description:

(COMPANY NAME) Biopharma Services are recruiting for a Project Manager to support the roll out of a new Quality system eQMS. The eQMS software has been adopted by (COMPANY NAME) BioPharmaceutical Services laboratories as the global quality and compliance management system and will be used worldwide by several hundreds of users in different laboratories. Following ITIL best practices, GAMP5 guidelines, Internal eQMS procedures and working instructions.
The mission of the Project Manager is to:
· Deploy eQMS in different laboratories worldwide in collaboration with the IT Manager in charge of Computerized Quality Systems for the quality processes;
· Manage overall project tasks, deployment or system optimization related, from inception to completion;
· Organize and coordinate requirements elicitation with business teams;
· Provide new requirements to business analyst so they can perform assessments for new and existing features;
· Follow-up design and functional specifications;
· Lead validation processes, including test plan and test script generation and coordination of work with Technical System Engineer(s);
· Prepare training material and train local resources on system features and implemented processes; · Author release notes related with implemented changes;
· Author, maintain and periodic review for all documents related with eQMS (requirements, specifications, traceability matrix, working instructions, SOP's, reports, etc.)
* Participate in the continuous improvement of IT Quality Assurance systems processes;
· Follow group policies and standards;
· Ensure follow-up to his Manager on a regular basis and as often as requested;
· Develop good practices;
· Author guidelines, procedures and templates for project management, system maintenance and validation;
· Improve system design to fulfil good practices and applicable regulations;
· Capitalize the knowledge base and help to improve the implemented processes.

Personal Skills:
* Autonomous, Proactive, Analytical, Rigorous, Business focused, Good communication and writing skills.
Qualifications & Experience
Education: Degree in Computer Sciences - Chemical or Biology background is a plus, Project Management Certification is a plus Solid IT knowledge from a design and functional perspective

Additional Information:

A large part of the work of the role involves interaction with all functions within (COMPANY NAME) BPT Laboratories as well as with clients. This will include planned regular team meetings, client meetings as well as ad hoc discussions across the business. For this reason, the person performing this role will need to be available at the Ireland site as required by clients / internal meetings.
There is likely to be a significant amount of time required to be spent at or travelling to client's sites across the territory (and occasionally beyond) consequently the job holder must be prepared to travel and this will involve nights away from home, it is anticipated that a minimum of 50% travel time is required per week