Change Control Coordinator

2 weeks ago


Hyderabad, Telangana, India Novartis Full time

Summary:

Handling of technical change control as well as responsibility for the documentation and coordination of the necessary activities during plant changes in Agile

About the Role:

Change Control Coordinator

About the Role:

Handling of technical change control as well as responsibility for the documentation and coordination of the necessary activities during plant changes in Agile

Key Responsibilities:

  • Should have good engineering knowledge in the Bio-Pharmaceutical Plant in the areas of
  • Facilities that are involved as infrastructure or in the manufacturing process, e.g. Ultrapure water systems, building services, manufacturing, packaging equipment (direct and indirect impact systems)
- the qualified status of a room or its classification (cleanroom zone E, D, C, B, A).
- the software and computer systems managed by Engineering.
- for new acquisitions of plants and systems/Equipment's
- on measuring equipment

  • SAP/Quality Management system software skills
  • Project planning Skills
  • Asset life cycle management skills eg maintenance documents and its metrics review
  • Should have sound knowledge about the Nomination of all participants in the QMS change phase from reviewer approver.
  • Should be good in all Engineering related changes which requires an evaluation & followed by a Registration Representative
  • Changes to ER/ES relevant systems, must be evaluated by eCompliance
  • In the case of devices, a DHF (Device Documentation File) evaluation may also be required. In the case of combination products, assembled and/or packaged, the MS&T "device expert" must check for adjustments with regard to device documentation (DHF file).
  • Implementation of the change and processing (or delegation) of the tasks defined in the implementation plan
  • Coordination of the change until completion

Essential Requirements:

  • 5+ years of experience in handling change controls within pharmaceutical sector
  • Very good knowledge of German and good knowledge of English (spoken and in writing)
  • Experience in the GMP or pharmaceutical sector.
  • Technical education, high level of personal responsibility, good communication skills

Desirable Requirements:

  • Degree or equivalent experience in Engineering with experience in Pharmaceutical Industry/ specifically GMP background
Division

Operations

Business Unit

Pharmaceuticals

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Technical Operations

Job Type

Full time

Employment Type

Regular

Shift Work

No

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