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    Msat- Team Member Nasal

    Dr Reddy's
    2+ years
    Not Disclosed
    India
    10 Aug. 21, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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: Process Qualification Specialist

    Job Description

    Responsibilities:

    • Product Transfer and Technology Absorption:

      • Oversee the transfer of products, including technology absorption and process qualification activities at FTO – SEZ Process Unit 1 Nasal.
      • Execute and monitor batches for Confirmatory, Submission, Pre-validation, and Process Qualification, ensuring effective technology transfer and ongoing process verification.

    • Process Improvement and Validation:

      • Perform and review investigations into incidents, out-of-specifications, out-of-trend results, product failures, and market complaints to identify root causes and implement corrective and preventive actions.
      • Evaluate process/product risks and recommend actions for proposed changes.
      • Review tooling drawings and change parts.
      • Participate in Process Safety Management activities, ensuring safety during the execution of Confirmatory, Submission, and Process Qualification batches.

    • Coordination and Documentation:

      • Coordinate with Production, Quality Assurance, Regulatory Affairs, Quality Control, Supply Chain Management, and vendors for data/report collection.
      • Prepare and review documents, including Confirmatory/Submission/Pre-validation/Process Qualification batch Protocols and Reports, Master Formula Records, Manufacturing Instructions, Packing Instructions, and Master Batch Records in Process Automation Systems (e.g., PAS|X).
      • Prepare and review material reservations in SAP.
      • Develop Equivalency and Justification Reports, Hold Time Study Protocols and Reports, Stability Protocols, and stability batch data reviews.
      • Handle license applications for technology transfer products and review Standard Operating Procedures (SOPs).
      • Compile and ensure compliance with Technology Transfer SOP Checklists.
      • Prepare SHE Reports for site transfer products.

    • Ongoing Process Verification:

      • Perform investigations related to ongoing process verification (OPV) of products.
      • Review Product Quality Reports (PQR).

    Qualifications:

    • Educational Qualification: M.Pharmacy or B.Pharmacy

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