The technical data quality expert is supposed to support a dedicated phase / workstream in the IDMP project to implement new data quality use cases with Informatica Data Quality solution. He/She shall design, develop and specify business rules for IDMP and Regulatory Information use cases. The responsible data quality expert shall not only be responsible for the design and development of business rules within Informatica, but also responsible to drive the deployment into all environments.
In terms of general approach and style, the most important characteristics are a strong sense of accountability and dedication to the project with a collaborative, inquisitive and detail orientated working style, and the willingness to push through challenges and difficulties.
- Derive project implementation plan that includes prioritizations and timelines
- Design and development of business rules for IDMP and RIMS use cases according to business user requirements
- Close alignment with business during design, development and deployment phase
- Creation of specification documents (Functional Specification, Design Specification, Risks) for all business rules
- Creation of testing documents for all business rules (OQ and PQ)
- Managing project risks and preparing the right response and mitigation approach for these
Requirements (Must have):
- Strong experience with Informatica Data Quality solution for considerable period of time (5+ years), preferably within pharmaceutical companies
- Proven specialist knowledge of pharmaceutical business processes e.g. Regulatory Affairs, Drug Safety, Clinical Operations
- Prior experience working within a validated and qualified systems environment, and an understanding of the challenges and complexities that this can bring to project delivery and timelines (optional on a case by case basis or industry)
- Detail and quality oriented individual, who is closely involved and understands the business needs, scope and deliverables to be executed by the project
- Collaborative working approach, willingness to engage stakeholders on a consistent basis to build ongoing relationships to further define and refine business needs onsite and remotely as needed
- Ability to react quickly and appropriately as required; knowing when to change the approach and when to persist with chosen approach
- Excellent communication skills, both one on one, and in larger groups. The technical lead should be able to distinguish relevant from non-relevant information and communicate in a concise manner that is both informative and thorough
- Demonstrated track record of efficiently and effectively managing a project
- Proven specialist knowledge of Informatica PowerCenter and Data Quality solution in the pharmaceutical industry
- Prior experience in completing a full computerized systems validation and testing methodology with awareness of the risks, issues, complications, and activities involved in these processes
- Proven knowledge of IDMP (Identification of Medicinal Product), EMA SPOR model and Regulatory Information Management Systems, SAP and Documentum
- Willingness to be on site - this would be a minimum of four to five days every month
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