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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 complying with safety requirements.


Key Accountabilities

  1. Technology Transfer Execution:

    • Carry out technology transfer activities at Contract Manufacturing Organizations (CMOs) and scale up batches at the plant for new molecules, ensuring the safe and effective transfer of processes.
  2. Validation Monitoring:

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

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

    • Gather data for plant hardware and provide insights for equipment mapping, aligning with process requirements to ensure efficient technology transfer.

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 processes.
    • Knowledge of critical process parameters during validation cycles.
    • Ability to monitor, document, and ensure compliance with SOPs for API transfers.
  2. Behavioral Competencies:

    • Collaborate to Succeed: Work with cross-functional teams to ensure seamless execution of technology transfer activities.
    • Innovate to Excel: Continuously optimize and improve the API technology transfer process to enhance efficiency.
    • Perform with Accountability: Ensure accurate documentation and execution throughout the technology transfer process.
    • Lead with Empathy: Provide training and share knowledge with staff to ensure successful technology transfer.
    • Act with Agility: Adapt to changing requirements and challenges in the technology transfer process.

Job Location

Bangalore


Shift Hours

(To be determined based on operational requirements)


This role offers an opportunity to lead and execute technology transfer activities for new API molecules, ensuring safe, compliant, and efficient processes in the manufacturing plant.