Overview
Senior Quality & Business Applications Specialist role at Pinewood Healthcare.
Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, employing over 320 people across two sites in Tipperary and Dublin. The Senior Quality & Business Applications Specialist is an SME utility role responsible for the deployment of applications that meet the specific business needs of Pinewood Healthcare, including managing the entire process of implementing Quality/Business applications from design and customization to testing and rollout.
Responsibilities
- Design product solutions in line with specifications provided by business managers; implement software and roll it out across the workforce; provide user support; and coach users.
- Lead implementation of key applications, including SAP Business Application and Trackwise quality management system.
- Act as SAP Subject Matter Expert (SME) for the site, covering all modules.
- Prepare SOPs and procedures for SAP and other applications.
- Project manage quality/business application implementations and ensure IT validation packages comply with Corporate and Local policies.
- Provide strategic consultation on IT Quality policies, procedures and best practices.
- Provide comprehensive SAP support for modules MM (Materials Management), PP (Production Planning), QM (Quality Management); perform SAP installation, configuration, tuning, and backups as required.
- Handle day-to-day functional tickets for MM, PP, and QM modules; troubleshoot issues and provide timely resolutions.
- Conduct SAP functional trainings for new users and refresher trainings for existing employees.
- Collaborate with users to gather requirements for SAP enhancements and optimizations; assist in creating and modifying master data (material master, BOMs, routings, inspection plans).
- Support QA team with reports from SAP; monitor data entry and ensure data integrity and regulatory compliance in MM, PP, and QM modules.
- Provide day-to-day support for SAP FICO (Finance); trackwise support and administration; review documents from other departments including their SOPs.
- Coordinate data upgrades/migrations and execute IQ/OQ and other validation processes; contribute to system validation documentation and compliance.
- Operate within ITIL service delivery processes and GMP validation processes; knowledge of GMP change control.
- Develop and maintain application-specific knowledge management; perform other ad hoc duties as needed.
Qualifications and Experience
- Bachelor's degree in Information Technology or Computer Science.
- Minimum of 8 years' professional experience in Quality/IT with full life-cycle implementation of Business Application Systems; SAP experience preferred.
- Strong programming, PL/SQL experience and software testing knowledge.
- In-depth knowledge of a best-practice project management methodology; experience managing third-party consultants.
- PMP training or certification preferred.
Additional Information
- Employment type: Full-time
- Job function: Quality Assurance
- Industry: Pharmaceutical Manufacturing
Tipperary, County Tipperary, Ireland