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Manager-2 - Rnd (Formulation Development)

Below 10 years
Not Disclosed
10 Jan. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Manager-2 - R&D (Formulation Development)
Date: December 17, 2024
Location: Halol 2 - MSTG - Formulation
Company: Sun Pharmaceutical Industries Ltd

Position: Manager-II

Department: MSTG

Grade: G11

Job Location: Dadra

Experience: Below 10 years

Job Description:

  • Support for Execution and Monitoring:
    Assist in the execution and monitoring of trial, scale-up, and exhibit process qualification batches.

  • New Product Documentation:
    Prepare and review documents for new products, including material requirement sheets, master formula cards, bill of materials, master formulas, risk assessment reports, sampling protocols, and reports for exhibit batch manufacturing.

  • Regulatory Compliance:
    Prepare and review product documents such as sampling protocols, trial batch reports, investigation reports, justification reports, additional activity protocols, and regulatory evaluations.

  • Regulatory Response:
    Provide responses to regulatory inquiries.

  • Cross-functional Collaboration:
    Share process knowledge with cross-functional departments through presentations to facilitate smooth technology transfer.

  • Process Improvement:
    Review and evaluate product history and process parameters for technical remediation and product robustness improvement.

  • Investigation Reporting:
    Prepare and submit investigation reports for OOS (Out of Specification), OOT (Out of Trend), and any failures during exhibit/validation/commercial batch manufacturing or stability testing.

  • Change Control and Deviations:
    Track activities related to change control, CAPA (Corrective and Preventive Actions), planned deviations, and unplanned deviations.

  • Risk Assessment:
    Prepare and review product containment approaches and risk assessment reports for new products, including assessments for elemental impurities, Nitrosamine impurities, and residual solvents.

  • Placebo and Quality Control Testing:
    Arrange placebos for quality control testing, change part development, and evaluate product feasibility.

  • Statistical Evaluation:
    Prepare and review statistical evaluations for process evaluations.

  • SOP and Training:
    Prepare and review Standard Operating Procedures (SOPs), training schedules, and conduct training.

  • Regulatory Audits:
    Participate in various regulatory audits to support the plant.