Senior Quality

1 week ago

Cluain Meala, County Tipperary, Ireland Pinewood Healthcare Full time

Business Applications & Compliance Specialist

3 weeks ago Be among the first 25 applicants

Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 320 people across two sites in Tipperary and Dublin. We now have an exciting opportunity for a Business Applications & Compliance Specialist.

The Business Applications & Compliance Specialist is an SME utility role that is responsible for the deployment of applications that meet the specific business needs of Pinewood Healthcare, to include: managing the entire process of implementing Quality/Business applications, from design/customisation, to creating, testing and rolling out the application. The main duties of the role-holder include designing a product solution in line with specifications given by business managers; implementing software and taking it live to across the workforce; offering support services for users; coaching users within the business and meeting with clients. Key applications at Pinewood that the role holder will be responsible for implementing include (1) SAP Business Application and (2) Trackwise quality management system. The role holder will also provide business module support, as well as software QA (SQA) support in creating, implementing and automating testing in support of software test requirements.

JOB CONTENT

Act as the SAP Subject Matter Expert (SME) for the site, covering all modules.
Prepare SOPs and procedures for SAP and other applications.
Project management of quality/business application implementations.
Ensure IT validation packages comply with Corporate and Local policies and procedures.
Provide strategic consultation on IT Quality policies, procedures and best practices.
Provide comprehensive SAP support for modules MM (Materials Management), PP (Production Planning), and QM (Quality Management).
Provide SAP technical support and troubleshooting for software application-related issues. Also performing SAP installation, configuration, tuning, or backups as required.
Handle day-to-day functional tickets for MM, PP, and QM modules, troubleshoot issues, and provide timely resolutions to ensure smooth business operations.
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 the creation and modification of master data in SAP, including material master, BOMs, routings, and inspection plans.
Support QA team in preparing PQR and other documents by providing reports from SAP.
Monitor and ensure the accuracy of transactions and data entry in MM, PP, and QM modules, maintaining data integrity and compliance with regulatory standards.
Provide day-to-day support for SAP FICO (Finance), addressing and resolving user issues.
Trackwise support and administration;
Review documents from other departments, including their SOPs.
Upgrade migration of data and execute IQ OQ and other validation processes;
Working experience in requirement analysis, design document creation and other validation documents;
ITIL service delivery processes and GMP validation processes;
Knowledge on GMP change control processes;
Develop system validation documentation and ensure the system validation compliance;
Create and manage application specific knowledge management;
Other ad hoc duties assigned as key responsibilities listed above are not exhaustive and may vary depending on the demands of the role.

Job Knowledge, Skills, Qualifications And Experience

Bachelor's degree in Information Technology or Computer Science.
Minimum of 8 years' professional experience in Quality/IT - full life-cycle implementation of Business Application Systems, SAP preferred.
Strong programming, PL/SQL experience and software testing knowledge required.
In-depth knowledge and practical experience of a best-practice project management methodology.
Experience of dealing with and managing third-party consultants in a project implementation.
PMP Training or certification will be preferred.

Seniority level

Not Applicable

Employment type

Full-time

Job function

Engineering and Information Technology

Industries

Pharmaceutical Manufacturing

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