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Associate Executive-Tech Transfer

3-5 years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Title: Associate Executive - Technology Transfer

Experience Required: 3-5 years of relevant experience
Location:
Mohali/Chandigarh
Compensation: 20-25% rise on current CTC

Key Responsibilities:

  • Technology Transfer Management:

    • Develop and execute plans for transferring pharmaceutical technologies (formulations, processes, equipment) between R&D, manufacturing sites, or different companies.

    • Identify risks during the technology transfer process and implement mitigation strategies to address them.

  • Documentation and Reporting:

    • Create, review, and maintain detailed documentation such as product development reports, master batch records, and process flow diagrams.

  • Formulation & Process Development:

    • Knowledge of design and development of tablet formulations, including pre-formulation studies, selection of excipients, and identification of Critical Quality Attributes (CQA), Critical Material Attributes (CMA), and Quality Target Product Profile (QTPP).

    • Perform formulation optimization and process optimization to ensure efficiency and scalability.

  • Cross-functional Coordination:

    • Collaborate with multiple teams, including manufacturing, quality assurance, and regulatory affairs, to ensure smooth technology transfer processes.

  • Regulatory Compliance:

    • Participate in regulatory submissions and ensure all documentation aligns with the requirements of regulatory bodies.

  • Troubleshooting and Process Support:

    • Assist in optimizing processes during technology transfer to ensure scalability and efficiency in manufacturing.

    • Provide troubleshooting support to resolve any technical difficulties during the scaling of processes or technology.