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Team Member - Api Tech Transfer

2-3 years
Not Disclosed
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: BE/BSc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description

Division:

IPD

Department:

IPD

Employment Type:

Permanent


Job Purpose

To execute and implement the API (Active Pharmaceutical Ingredient) technology transfer activities at the plant, ensuring the robustness of processes while adhering to safety requirements.


Key Accountabilities

  1. Technology Transfer Execution:

    • Implement technology transfer activities at Contract Manufacturing Organizations (CMO) and scale up batches at the plant for new molecules. Ensure safe and effective transfer of processes.
  2. Pre-Validation and Validation Monitoring:

    • Oversee the pre-validation and validation cycle batches at the plant. Conduct training sessions for shop floor staff to ensure accurate identification and management of critical process parameters.
  3. Documentation Compliance:

    • Prepare and maintain documentation in compliance with Standard Operating Procedures (SOPs) for API technology transfer processes.
  4. Data Compilation and Equipment Mapping:

    • Gather and compile data related to plant hardware. Provide inputs for mapping equipment in alignment with process requirements.

Educational Qualifications

  • B. E. in Chemical Engineering or
  • B.Sc. in Organic Chemistry

Relevant Experience

  • 2 to 3 years of experience in manufacturing or technology transfer, particularly in API processes.

Competencies and Skills

  1. Core Competencies:

    • Expertise in API technology transfer and manufacturing processes.
    • Ability to monitor and manage critical process parameters during validation cycles.
  2. Behavioral Competencies:

    • Collaborate to Succeed: Work closely with cross-functional teams to ensure smooth technology transfer and process implementation.
    • Innovate to Excel: Contribute innovative ideas to optimize API technology transfer activities and enhance process robustness.
    • Perform with Accountability: Ensure accurate execution and documentation throughout the technology transfer process.
    • Lead with Empathy: Support and train staff to foster knowledge sharing and successful process transfers.
    • Act with Agility: Adapt quickly to changing processes or issues encountered during technology transfer activities.

Job Location

Kurkumbh


Shift Hours

(To be determined based on operational requirements)


This position offers an exciting opportunity to contribute to the successful technology transfer of API processes, ensuring safety, quality, and operational excellence at the plant.