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Team Member - Formulation Tech Transfer

5-7 years
Not Disclosed
10 Dec. 31, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm 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 formulation technology transfer activities across all Cipla sites and Contract Manufacturing Organizations (CMOs), ensuring the standardization, strengthening, and improvement of technology transfer processes and systems in compliance with regulatory guidelines.


Key Accountabilities

  1. Knowledge Transfer:

    • Conduct effective transfer of knowledge about products and processes to formulation manufacturing units.
    • Provide required documentation to support successful implementation of new product technology.
  2. Requirement Analysis:

    • Identify and document the requirements and prerequisites (raw materials, packaging materials, tooling, accessories, machines, etc.) for batch execution as per the monthly rolling plan.
  3. Batch Execution:

    • Participate in the execution of placebo, feasibility, assessment, regulatory, and amendment batches within defined timeframes.
  4. Data Management:

    • Gather and compile batch, process, in-process, physical, analytical, and stability data for dossier preparation.
  5. Control Strategy:

    • Assist in evaluating and extrapolating acquired batch data during the transfer process to define control strategies for commercial launches.
  6. Technical Support:

    • Provide technical support to implement Continuous Improvement Processes (CIP), Analytical Validation Data (AVD), and site transfer activities to drive product life cycle management and sustain growth.
  7. CMO Tech Transfer:

    • Actively participate in technology transfer activities for new products at Contract Manufacturing Organizations (CMOs).

Qualifications

  • Education:

    • Bachelor’s degree (B.Pharm) or Master’s degree (M.Pharm) in Pharmacy.
  • Experience:

    • 5-7 years of experience in formulation development and/or manufacturing.
    • Comprehensive knowledge of regulatory markets and guidelines.

Key Competencies and Skills

  • Core Competencies:

    • Expertise in formulation technology transfer.
    • Strong understanding of regulatory requirements and standards.
    • Experience in managing end-to-end tech transfer processes.
  • Behavioral Competencies:

    • Collaborate to Succeed: Work effectively with cross-functional teams.
    • Innovate to Excel: Drive innovation in tech transfer and process improvements.
    • Perform with Accountability: Take ownership of tasks and ensure timely completion.
    • Lead with Empathy: Build and maintain strong relationships with stakeholders.
    • Act with Agility: Adapt to changing priorities and challenges.
  • Additional Skills:

    • Data analysis and reporting.
    • Effective communication and documentation.
    • Problem-solving and decision-making.

Job Location

Vikhroli


Shift Hours

(To be determined based on operational requirements)


This role provides an excellent opportunity to contribute to Cipla's growth by leveraging your expertise in formulation technology transfer. If you are passionate about ensuring seamless tech transfer and compliance, this position is ideal for you!