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Msat- Team Member Nasal

0-2 years
Not Disclosed
10 Jan. 4, 2025
Job Description
Job Type: Full Time Education: B.Pharma, 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

Position: Product Transfer & Process Qualification Specialist
Location: FTO – SEZ Process Unit 1 Nasal


Responsibilities:

  1. Product Transfer & Technology Absorption:

    • Oversee the product transfer and technology absorption processes, ensuring successful integration at the FTO – SEZ Process Unit 1 Nasal facility.
    • Execute and monitor confirmatory, submission, pre-validation, and process qualification batches.
    • Support activities such as technology transfer, continued process verification, process simplification, machine changes, and batch size modifications.
  2. Validation and Qualification:

    • Manage routine validation and qualification activities, ensuring compliance with regulatory and organizational standards.
    • Prepare and review validation protocols and reports for confirmatory, submission, and process qualification batches.
  3. Investigations and Corrective Actions:

    • Perform and review investigations for incidents, out-of-specifications (OOS), out-of-trends (OOT), product failures, and market complaints.
    • Identify root causes and implement corrective and preventive actions (CAPA).
  4. Process Risk Evaluation:

    • Evaluate risks associated with processes and products, providing recommendations for proposed changes.
    • Review tooling drawings and change parts to ensure suitability and compliance.
  5. Documentation and Reporting:

    • Prepare and review critical documents, including:
      • Confirmatory, submission, pre-validation, and process qualification protocols and reports.
      • Master Formula Records, Manufacturing Instructions, and Packing Instructions.
      • Stability protocols and stability batch data reviews.
      • Product quality review (PQR) reports and equivalency/justification reports.
    • Maintain compliance with technology transfer SOP checklists.
  6. Coordination:

    • Collaborate with cross-functional teams, including Production, Quality Assurance, Regulatory Affairs, Quality Control, Supply Chain Management, and vendors for data collection and reporting.
  7. Safety and Compliance:

    • Participate in Process Safety Management activities and implement safety measures during batch execution.
    • Prepare SHE (Safety, Health, and Environment) reports for site transfer products.
  8. System Management:

    • Utilize tools like PAS|X for process automation and SAP for material reservation and management.
  9. Investigations and Ongoing Process Verification (OPV):

    • Conduct investigations related to OPV and ensure timely resolutions.

Qualifications:

  • Educational Requirements:

    • M. Pharmacy or B. Pharmacy degree.
  • Skills & Attributes:

    • Strong knowledge of technology transfer processes and validation techniques.
    • Familiarity with quality assurance and compliance requirements.
    • Excellent documentation and analytical skills.
    • Proficiency in software tools such as PAS|X and SAP.
    • Effective collaboration and communication skills for cross-functional coordination.

Join Dr. Reddy’s Laboratories and contribute to making innovative healthcare solutions accessible worldwide.