Manufacturing Process Specialist

4 weeks ago


Bengaluru, Karnataka, India Tata Consultancy Services Full time

Tata Consultancy Services is seeking a skilled Manufacturing Process Specialist to join our team.

Key Responsibilities:

  • Develop and implement manufacturing process plans, process verification & validation, and equipment qualification (IQ/OQ/PQ) protocols & reports.
  • Create process risk management documentation such as process FMEAs.
  • Manage product variants and set up the Bill of Material and routers.
  • Collaborate with cross-functional teams such as packaging, labeling, and production planning.
  • Ensure compliance with EU MDR and FDA requirements.
  • Work with chemical products such as liquid and powder.
  • Proficient in MS Office applications such as MS Word, PowerPoint, and Excel.
  • Strong communication and interpersonal skills.
  • Ability to work independently with minimal guidance.
  • Flexibility to accommodate additional effort needed to meet project and organizational deadlines.

Requirements:

  • Prior experience in Medical Devices Domain.
  • Knowledge about IQ/OQ/PQ and Validation Activities.

Preferred Qualifications:

  • Knowledge of PLM Change Management Process.
  • Experience with Bill of Material and routers set-up.
  • Knowledge of Process FMEAs and Manufacturing control plan.
  • Equipment & Process Qualification (IQ/OQ/PQ).

Education:

Degree in Manufacturing/Mechanical/Production engineering/equivalent.

Responsibilities include creating and updating manufacturing process plans, work instructions, manufacturing process specification, and validation documents.

Perform gap assessment between legacy process validation and current standard. Coordinate with team for gap remediation.



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