IT PROJECTS AND COMPLIANCE LEADER

IT

IT PROJECTS AND COMPLIANCE LEADER

MAURITIUS

MARKET RELATED + RELOCATION

 Purpose:

 This role is responsible for delivering the IT project portfolio by leading a team of project and validation analysts. Developing and managing project definitions and plans, and then ensuring that all the projects are delivered on time, to budget and to the required IT quality management standard.  Ensures the projects are effectively resourced, and manages relationships with a wide range of customers and suppliers.  The role also defines and manages compliance, computer system validation and activities for the IT systems, and acts as a link from global to regional offices

Specific Outcomes / Accountability:

  • Analyzes, researches, organizes and supervises IT related projects as assigned by the IT Manager.
  • Project management and coordination of the program of projects involving business applications, interfaces and infrastructure within the Aspen group and with external business partners;
  • Work with internal and external customers to ensure projects meet business needs;
  • Apply risk based approach principles to author and review validation documents supporting GxP computerized systems and relevant infrastructure;
  • Work with IT team members to improve project delivery and compliance processes within the steam;
  • Collaborate with other IT members, Quality Officer and business functions on systems validation efforts and the improvement of existing IT Quality processes/practices;
  • Provide oversight of IT policies, procedures and computer validation activities to assure compliance with company policies, standard operating procedures and regulatory requirements;
  • Oversee the execution of testing in support of change control to computerized systems including SOPs, scripts and reports;
  • Work with regional teams to ensure global project and validation strategies are understood and followed;
  • Provide IT business integrator expertise for systems supporting the project and quality processes;
  • Support the IT Audit process to ensure risks are mitigated in a timely manor;
  • Mentor and train other IT Analysts.

 

 

Qualifications & Experience:

  • Bachelors degree in Business Administration, Management Information Systems, or related discipline, or equivalent work experience in a related field
  • Track record of providing IT solutions and liaising with different business areas to attend to unmet needs. Previous ERP project experience needed, including B2B integration.
  • Must have strong technical background, along with demonstrated leadership with commitment to process and quality orientation
  • Demonstrated ability to create, manage and complete complex projects using project management processes, tools and methods
  • Pharmaceutical industry experience would be a plus;
  • 6+ years of quality management experience in validation of computerized systems of varying complexity;
  • Knowledgeable with computerized systems regulations of the US and EU (21 CFR Part 11 & Validation);
  • Good understanding of life cycle development and implementation processes;
  • Familiar with risk based approach concepts and application to validation strategies and activities;
  • Strong communication skills, both written and oral and ability to work efficiently with peers, end users, management, and outside vendors
  • Ability to coordinate requests from different business areas and work under pressure
  • Desired experience with Prince 2

 

PLEASE SEND THE FOLLOWING to jill@thecandidate.co.za

  1. Copy of CV in WORD format
  2. Copy of last payslip
  3. Copy of qualifications
  4. Skype Address
  5. 2 contactable referees, if you have any written references, please send those

 

If you have not had a response within 7 days your application has been unsuccessful.

 

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