As a Senior IT Systems Analyst for QC Applications, you will be responsible for operations and maintenance of the systems in your domain particularly Labware LIMS and Empower. Your key objective will be to continuously improve business operations and to ensure compliance/alignment between the different requirements at different levels and from different stakeholders of the organization.
You will be the lead site contact to the vendors and responsible for coordinating all updates to the systems, report and track technical issues, proactively manage licenses of the systems.
You will be responsible for second level support of the system, maintain a knowledge base for first level support as well as promote best practices in the applications utilization.
The role also includes smaller project management tasks, like driving upgrade projects and secure operation management is considered, participate as a technical lead in Global IT and compliance projects, initiate and drive own optimization projects, in cooperation with vendor if required.
The role supports the maintaining of the validated state of the systems throughout the life cycle. This role requires developing and documenting the specialist technical knowledge and transferring technical knowledge to peers and the business.
Principal Accountabilities and Main Responsibilities:
- Provision of timely and effective support to ensure the satisfaction of internal customers. Understand and anticipate the needs to enhance the quality-of-service delivery (15%).
- Responsible for ensuring the reliability, availability, and security of systems/technologies under your management. Keeping up to date with technological advancements and implementing system and process improvements in your area (15%).
- Adherence to ITIL or relevant IT service management (ITSM) frameworks is expected, along with the responsibility for documenting and refining IT processes to increase operational efficiency and effectiveness (20%).
- Compile technology related documentation for GxP and critical IT technologies. Participate in system validation and testing processes as required. Approve validation documentation together with relevant IT QMS documentation (20%).
- Manage or contribute to IT projects, ensuring they meet deadlines and stay within budget. Employing best practices in project management (15%).
- Establishing and maintaining relationships with technology vendors and service providers. Managing vendor performance to ensure the company receives value from them (15%).
- Other job duties that may be assigned, including supporting and administering any applications that are added to the Technical Operations QC IT group portfolio.
Minimum Education and Experience Requirements:
- Msc or B.Sc within computer science, business administration, engineering or similar, preferably with background in automation in production.
- 15+ years in IT systems operation and maintenance, preferably within the pharmaceutical industry. Experience in production, IT project management, and system administration. Documented ISO compliance, strong understanding of cGMP, and knowledge of GAMP. Personality traits: Quality-oriented, structured, analytical, proactive, with excellent networking and interpersonal skills, and high responsibility.
Experience administering Labware LIMS and Empower applications.
- Labware LIMS and/or Waters Empower administration certifications are desired.
Knowledge and Skills:
- Excellent oral and written communications skills and fluency in English.
- Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
- Pharmaceutical experience is required.
- Ability to prioritize and work autonomously based on common goals and objectives.
- You have a strong analytical mind, eye for detail and problem-solving skills. You have a natural drive for simplification.
- Quality minded.
- Strong analytical skills.
- High sense of responsibility.
- Willingness to learn new things.
- Experience with QC and QA processes is an advantage.
- Working knowledge of software maintenance in a regulated environment. Documented ISO and cGMP understanding and knowledge of GAMP.
- Experience in IT projects.
