Msat- Team Member Nasal

Dr.Reddy's

0-2 years

Not Disclosed

Pydibimavaram

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:

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.
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.
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).
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.
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.
Coordination:
- Collaborate with cross-functional teams, including Production, Quality Assurance, Regulatory Affairs, Quality Control, Supply Chain Management, and vendors for data collection and reporting.
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.
System Management:
- Utilize tools like PAS|X for process automation and SAP for material reservation and management.
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.

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Msat- Team Member Nasal

Job Description

Job Description

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Qualifications:

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