Job Description

Senior Analyst, Scientific IT
Contract Pharmaceuticals Limited is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry. Realize the business benefits, while optimizing risks and resources, from the use of Information Technology across the scientific divisions. Product Development (PD) and Quality, including systems and computerized inventory instruments.
SPECIFIC RESPONSIBILITIES: For the scientific divisions of the organization: PD and Quality, and following the compliance guidelines relevant to CPL\xe2\x80\x99s business operation (e.g. cGMP/GLP/GAMP/GALP), achieve the following objectives pertaining to Information Technology: Managed Enterprise Architecture: Establish a common architecture consisting of business process, information, data, application and technology architecture layers based on the technology pertaining to the PD and QA areas, including all computerized laboratory instruments.
Managed Portfolio: Execute the strategic direction set for investments in line with the enterprise architecture vision and I&T road map for the PD and QA areas. Evaluate, prioritize and balance programs and services.
Managed Relationships: Manage relationships with PD and QA business stakeholders in a formalized and transparent way that ensures mutual trust and a combined focus on achieving the strategic goals within the constraints of budgets and risk tolerance. Base relationships on open and transparent communication, a common language, and the willingness to take ownership and accountability for key decisions on both sides. Business and IT must work together to create successful enterprise outcomes in support of the enterprise objectives.
Managed Service Agreements: Align I&T-enabled products and services and service levels with the PD and QA departments\xe2\x80\x99 needs and expectations, including identification, specification, design, publishing, agreement, and monitoring of I&T products and services, service levels and performance indicators.
Managed Vendors: Manage I&T-related products and services provided by all types of vendors to meet PD and QA requirements. This includes the search for and selection of vendors, management of relationships, and reviewing and monitoring of vendor performance and vendor ecosystem for effectiveness and compliance.
Managed Quality: Define and communicate quality requirements in all processes, procedures and related PD and QA outcomes. Enable controls, ongoing monitoring, and the use of proven practices and standards in continuous improvement and efficiency efforts.
Managed Risk: Continually identify, assess and reduce I&T-related risk within tolerance levels set by enterprise executive management.
Managed programs/projects: Manage programs/projects from the ID and QA portfolio in alignment with enterprise strategy and in a coordinated way, based on a standard program/project management approach. Initiate, plan, control, and execute programs, and monitor expected value from the program/project.
Managed Requirements Definition: Identify solutions and analyze requirements before acquisition or creation to ensure that they align with enterprise strategic requirements covering business processes, applications, information/data, infrastructure and services. Coordinate the review of feasible options with affected stakeholders, including relative costs and benefits, risk analysis, and approval of requirements and proposed solutions. Managed Solutions Identification and Build: Establish and maintain identified products and services (technology, business processes and workflows) in line with enterprise requirements covering design, development, procurement/sourcing and partnering with vendors. Manage configuration, test preparation, testing, requirements management and maintenance of business processes, applications, information/data, infrastructure and services.
Managed Availability and Capacity: Balance current and future needs for availability, performance and capacity with cost-effective service provision. Include assessment of current capabilities, forecasting of future needs based on business requirements, analysis of business impacts, and assessment of risk to plan and implement actions to meet the identified requirements.
Managed organizational change: Maximize the likelihood of successfully implementing sustainable PD and QA organizational change quickly and with reduced risk. Cover the complete life cycle of the change and all affected stakeholders in the business and IT.
Managed IT changes: Manage PD and QA changes in a controlled manner, including standard changes and emergency maintenance relating to business processes, applications and infrastructure. This includes change standards and procedures, impact assessment, prioritization and authorization, emergency changes, tracking, reporting, closure, and documentation.
Managed IT change acceptance and transitioning: Formally accept and make operational new solutions. Include implementation planning, system and data conversion, acceptance testing, communication, release preparation, promotion to production of new or changed business processes and I&T services, early production support, and a post-implementation review.
Managed Configuration: Define and maintain descriptions and relationships among key resources and capabilities required to deliver I&T-enabled services for the PD and QA. Include collecting configuration information, establishing baselines, verifying and auditing configuration information, and updating the configuration repository.
With the support of the manager, IT operations and compliance, achieve the following objectives:
Managed security. Managed operations. Managed service requests and incidents. Managed problems. Managed continuity. Managed security services. Managed business process controls. Managed assets.
With the rest of the IT management team, achieve the following objectives:
Ensured Governance Framework Setting and Maintenance Ensured Benefits Delivery Ensured Risk Optimisation Ensured Resource Optimisation Ensured Stakeholder Transparency Managed Performance and Conformance Monitoring Managed System of Internal Control Managed Compliance with External Requirements Managed Assurance
QUALIFICATIONS:

• 
  University or college degree in a related technical field.
• Approx. 5 years of experience in increasingly responsible business analysis roles.
• Experience (5+ years) in designing, implementing and supporting manufacturing, packaging, engineering or maintenance IT solutions.
• Project Management Professional (PMP) certification or related experience.
• Experience in pharmaceutical or similarly regulated industry.
• Working knowledge of regulations, such as 21CFR Part 11, Good Automated Manufacturing Practice (GAMP5), GLP and Good Automated Laboratory Practice (GALP) and pharmaceutical manufacturing compliance (Computer Systems Validation).
• Significant experience in quality information systems such as Laboratory Information Management Systems (LIMS), Quality systems (such as TrackWise), Empower and SAP Quality Management (QM, Laboratory Standalone computerized systems (such as UVS, FTIR), SharePoint.
• Demonstrated competencies in CPL\xe2\x80\x99s core values of Integrity, Fairness, Trust and Respect.
• Strong critical and analytical skills rounded by solid presentation and influencing skills.
• Excellent verbal and written English communication skills.
• Proven ability to manage multiple tasks or projects.
• Proven history of successful project deliverables.
• Training in Lean preferred.
• Experience with at least one Systems Development Lifecycle Management (SDLC) methodology.

PHYSICAL DEMANDS/WORKING CONDITIONS:

• 
  Standard office conditions.

CPL is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. CPL is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation polices, please contact us. We thank all applicants for their expression of interest; however only those selected for an interview will be contacted. No phone calls or agencies please.