CHANGE CONTROL MANAGER [ MNC MANUFACTURER, ISKANDAR PUTERI ]
Specialisation: Manufacturing/Production Operations
Education Qualification: Bachelor Degree
Work Location : Iskandar Puteri, Johor
Salary Range : RM 10,000.00 – 15,000.00
Posted Date : August 23, 2019
- Provide change management, master data maintenance and front-line application support for applicable systems on behalf of COMPANY
- You are responsible to track and manage CMN master data management and business configuration.
- This includes user accounts, product dictionaries, regulatory rules, document templates, etc.
- Act as a process owner for Master Data activities and work closely with the management team / IRB to ensure that the process remains effective and works efficiently
- Ensure all configuration changes are tested and validated in accordance to process and regulatory / Quality obligations.
- 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).
- Manage, support and execute user acceptance testing (UAT) for complex submission rules.
- Contribute to the core business and informatics processes and solutions within a specific area of a domain, applying knowledge of systems and tools and problem solving skills to the support of these processes and solutions.
- Contribute to configuration and adaptation efforts to ensure the solution is fit for purpose.
- Coordinate with various stakeholders in the process of service delivery and support, including internal and external service providers.
- 5-8 years of experience in supporting highly regulated applications, preferably within Pharma business domain and technology, and have proficient knowledge of Biopharmaceutical 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 highly preferred.
- experience in working in a regulated environment and with Computer System Validation. Working knowledge of industry standard safety systems
- experience in resolving complex issues in a technically complex system
Kindly contact the following consultant at 07-2305453 for further details or send your resume to Talent Resource Unit [ email@example.com ] / Mr Hanafi [ firstname.lastname@example.org ]