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CHANGE CONTROL MANAGER [ MNC MANUFACTURER, ISKANDAR PUTERI ]

Specialisation: Manufacturing/Production Operations
Education Qualification: Bachelor Degree
Master Degree
Professional Degree
Work Location : Iskandar Puteri, Johor
Salary Range : RM 10,000.00 – 15,000.00
Posted Date : August 23, 2019

Job Responsibilities

  1. Provide change management, master data maintenance and front-line application support for applicable systems on behalf of COMPANY
  2. You are responsible to track and manage CMN master data management and business configuration.
  3. This includes user accounts, product dictionaries, regulatory rules, document templates, etc.
  4. 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
  5. Ensure all configuration changes are tested and validated in accordance to process and regulatory / Quality obligations.
  6. Measure and report on all configuration changes and provide control on governance on how configuration changes are tested, approve and move to production systems. 
  7. Update and manage Submission Rules (fix discrepancies, define and implement rules, testing and support).
  8. Manage, support and execute user acceptance testing (UAT) for complex submission rules. 
  9. 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. 
  10. Contribute to configuration and adaptation efforts to ensure the solution is fit for purpose. 
  11. Coordinate with various stakeholders in the process of service delivery and support, including internal and external service providers.

Qualifications

  1. 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
  2. Knowledge of drug safety regulatory obligations and guidelines or other relevant experience in the drug development environment within the pharmaceutical industry is highly preferred.
  3. experience in working in a regulated environment and with Computer System Validation. Working knowledge of industry standard safety systems
  4. 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 [ cr-talentresource3@cityrecruit.com.my ] / Mr Hanafi  [ mohd.haron@cityrecruit.com.my ]