Scientific Research Specialist

2 days ago

Dholka, Gujarat, India beBeeTechnical Full time ₹ 9,00,000 - ₹ 12,00,000
Senior Technical Specialist Job Description

We are seeking a highly skilled Senior Technical Specialist to support the development and implementation of production processes.

Responsibilities:

  • Develop and execute alternate vendor batch execution and process improvement plans.
  • Manage change in batch size, troubleshoot at shop floor, equipment change activities of product after technology transfer completion.
  • Determine optimal batch sizes for scale up, exhibit, and commercial batches to meet equipment capacities and regulatory requirements.
  • Prepare/review relevant documents like SOP, Batch Manufacturing Record, Sampling Protocol, Hold time study protocol/report, stability study protocol/report, Process validation protocol and Report.
  • Provide technical support for change management, investigations of deviations or OOS, CAPA identification, and QMS related activities.
  • Ensure cGMP and Regulatory compliance.

Requirements:

  • Strong knowledge of cGMP and regulatory requirements.
  • Excellent problem-solving and analytical skills.
  • Ability to work effectively in a team environment.
  • Effective communication and interpersonal skills.

Working Conditions:

  • Work in a fast-paced manufacturing environment.
  • Collaborate with cross-functional teams to achieve business objectives.

This role involves working closely with various stakeholders to drive operational excellence and ensure compliance with regulatory standards. The ideal candidate will have a strong technical background and excellent communication skills. If you are passionate about delivering high-quality results and driving process improvements, we encourage you to apply for this exciting opportunity.

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