Job Description

The Position

Number of Subordinates (If any)

No direct reports.

Required experience & Qualification:

Years of relevant working experience

• A minimum of 10 years of experience in IT

Academic Requirement

• Bachelor\'s degree in Information Technology, or a related Engineering discipline (or equivalent experience).

Key competencies

• Passionate about learning, sharing and further developing \xe2\x80\x9cbest practice\xe2\x80\x9d and embed it as \xe2\x80\x9cnext practice\xe2\x80\x9d to achieve greater impact
• Good enough instead of perfection
• Exhibits servant leadership behavior, self-aware leader and a flexible team-player in a multi-cultural environment
• Agile competencies: having a growth mindset, knowing yourself, being courageous and get connected

Strong attention to detail

Strong analytical skills

Good in documentation

Good team player

Key responsibilities

Master data Specialist plays multiple roles, with each role having specific responsibilities.

Master Data Management

• You are responsible to track and manage PVIS (PV Intelligent Automation & Business Systems Solutions) master data and business configuration. This includes:
• User accounts management, product dictionaries, regulatory rules, document templates, etc.
• Act as a process owner for Master Data activities and work closely with the management team to ensure that the process remains effective and works efficiently.

Configuration Management

• Ensure PVIS Configuration Items are maintained correctly in our Configuration Management and related systems. You are responsible
• To track all version of changes that have been configure and provide reports on any configuration bugs or defects.
• Provide support, administration and change management for Drug Safety systems under the ownership of PVIS. You will be responsible to manage, update and validate current and future changes to configuration of PDS computer solutions.
• Ensure all configuration changes are tested and validated in accordance to PVIS rules and regulatory obligations to drug safety management.
• Measure and report on all configuration changes and provide control on governance on how configuration changes are tested, approve and move to production systems.
• Update and manage Submission Rules (fix discrepancies, define and implement rules, testing and support)

Domain Expert

• Maintain a good understanding of business processes and context in which the IT services are consumed within the Drug Safety or any others regulated industries
• Apply knowledge of systems, tools and problem solving skills in the respective domain.
• Continual self-development to maintain up-to-date knowledge of the industry and domain of specialization.

Technical Expert

• Apply hands-on skills in the underlying technologies required to operate, maintain and enhance the solutions.
• Manage, support and execute user acceptance testing (UAT) for complex submission rules

Project Management

• Act as squad lead or squad team member for global project within Product and Service Management Chapter

Qualifications

• You have 5-10 years of Master Data Management Operation experience
• You have 5-10 years of experience in supporting highly regulated applications, preferably within the Pharma business domain and technology, and have proficient knowledge of pharmaceutical technology and processes.
• Knowledge of drug safety regulatory obligations and guidelines or other relevant experience in the drug development environment within the pharmaceutical industry is an added advanta.
• You have relevant experience with SQL Database Administration
• You have experience in creation of UAT plan and Test Cases based on business requirements
• You have experience in working in a regulated environment and with Computer System Validation. Working knowledge of industry standard safety systems
• You have experience in resolving complex issues in a technically complex system.
• You have experience in delivering service in a mission-critical environment.
• You are able to communicate fluently and effectively in English (written and spoken).
• ITIL certification is an advantage

Working hours

Normal hours with flexibility to participate in virtual meetings outside of normal hours, public holidays and core working hours from 10am to 7pm.

Roche is an equal opportunity employer.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The Roche Services & Solutions as well as People Support Solutions organisations located in Kuala Lumpur provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the APAC region. Today Roche employs altogether around 1100 employees in Malaysia.

Roche is an Equal Opportunity Employer.

Roche