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Validation Coordinator (Utilities)

Dalitso Holdings
Midrand Full-day Full-time

Description:

  • Provide technical support to all departments in accordance with established Service Level Agreements and company standards.
  • Responsible for ensuring that qualification of utilities is carried out in accordance with manufacturing procedures and policies, cGMP, and relevant guidelines.
  • Generate, execute and/or review completed qualification protocols and associated data for conformance to applicable acceptance criteria.
  • Coordinate timely completion of utilities qualification in support of manufacturing activities and Regulatory requirements (writing, reviewing and execution of qualification protocols and reports).

    Minimum Requirements:

  • Bachelor’s degree Mechanical/ Electrical Engineering /Biotechnology /Biochemistry
Experience in pharmaceutical industry experience, with at least 3 years in Validation/ Qualification/ Utility support Knowledge of HVAC, Water for Injection, Purified Water, Compressed Air and Clean Steam and Nitrogen systems Demonstrate ability to provide technical solutions for complex problems through qualification knowledge. Proficient in the use of structured problem-solving tools such as Process Mapping, RCA (Root cause analysis), FMEA's (Failure Mode effects analysis) etc. In depth understanding of utilities and engineering Excellent communication and interpersonal skills Ability to work independently Overtime from time to time will be required so flexibility will be important.

Core Competencies:

Relating and networking Presenting and communicating information Working with people Deciding and initiating action Delivering results and meeting customer expectations Planning and organising Writing and reporting Applying expertise and technology Coping with pressure and setbacks Achieving personal work goals and objectives Adhering to principles and values


Additional Info:
3 to 5 years

Salary: RR400000 to R480000

Job Reference #: 2605910194

19 May 2022;   from: gumtree.co.za

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