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Msat- Team Member Nasal

3+ years
Not Disclosed
12 Nov. 26, 2024
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 Opportunity: Technology Transfer & Process Qualification Specialist (Nasal Products)

Job Description: Dr. Reddy’s Laboratories is seeking a Technology Transfer & Process Qualification Specialist for their FTO-SEZ Process Unit 1, focusing on nasal products. This role involves overseeing product transfers, technology absorption, and process qualification activities, ensuring smooth execution, validation, and compliance.

Key Responsibilities:

  • Manage product transfer, technology absorption, and process qualification activities for nasal products.
  • Execute and monitor confirmatory, submission, pre-validation, and process qualification batches.
  • Conduct investigations into incidents, out-of-specifications, product failures, and complaints to identify root causes and implement corrective actions.
  • Evaluate product/process risks and recommend changes where necessary.
  • Review tooling drawings, change parts, and ensure safety during process qualification batches.
  • Coordinate with multiple departments, including Production, QA, Regulatory Affairs, QC, Supply Chain, and vendors for data collection and reporting.
  • Prepare and review essential documentation such as:
    • Confirmatory/Submission/Pre-validation/Process qualification batch protocols & reports.
    • Master Formula Record, Manufacturing Instructions, Process Orders, and Batch Records in the PAS|X system.
    • Equivalency/Justification Reports, Hold Time Studies, Stability Protocols, and Reports.
  • Oversee license application processes for technology transfer products and ensure compliance with SOPs.
  • Prepare and review SHE reports related to product transfer activities and ongoing process verification (OPV).

Qualifications & Skills:

  • Educational Requirements: M. Pharma/B. Pharma.
  • Experience: Proven experience in technology transfer, process qualification, and manufacturing in the pharmaceutical industry.
  • Technical Skills: Expertise in product/process risk evaluations, batch protocols, and relevant documentation.
  • Behavioral Skills: Strong attention to detail, problem-solving, teamwork, and communication skills.

Additional Information:

  • Location: FTO-SEZ Process Unit 1, Nasal Products.
  • Role Focus: Ensuring product transfer and qualification processes meet regulatory standards, safety requirements, and manufacturing efficiencies.

Apply Now: Visit Dr. Reddy's Careers portal to apply and explore further opportunities with us.