Deputy Manager, Materials Handling

0 years

0 Lacs

Posted:1 month ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • Preparation of URS prior to procurement of new equipment.
  • Preparation of Qualification documents i.e. IQ/OQ/PQ for area / equipment’s and its approval & Execution of the activities.
  • Identify need of new SOP’s for adequate procedural control on Warehouse activities.
  • Preparation of new SOP’s and existing SOP’s as per requirement.
  • Day to day basis review of SOP’s and its updation and implementation in co-ordination with CFT members.
  • Perform Re-qualification / Calibration of equipment as per the stipulated timeline in co-ordination with CFT.
  • Handling of various types of deviations / Incidents / Change controls / CAPA’s related to Warehouse.
  • Preparation of Risk assessment and Impact assessment documents.
  • Preparation of supporting documents related to deviation / incidents by following 5-Why, 6M (Fish bone analysis), Genchi Genbutsu techniques etc.
  • Timely compliance to internal / external regulatory audits i.e. self-inspection, customer & regulatory agencies.
  • Good knowledge on SAP MM, WM and SD modules and Microsoft office i.e. word/excel/PowerPoint.
  • Exposure for handling regulatory / customer audits i.e. USFDA/MHRA/WHO/TGA/ANVISA/EMA/MCC etc.

Skills

QUALIFICATIONS

Technical Skills

  • Computer System Validation (CSV) – IQ/OQ/PQ documentation and execution
  • SOP drafting, review, and implementation
  • Risk Assessment & Impact Analysis
  • Handling deviations, incidents, change controls, and CAPA
  • SAP MM, WM, and SD modules
  • Proficiency in MS Office (Word, Excel, PowerPoint)

Compliance & Regulatory

  • Knowledge of cGMP, GAMP5, 21 CFR Part 11, EU Annex 11
  • Audit readiness and experience with USFDA, MHRA, WHO, TGA, ANVISA, EMA, MCC audits

Analytical & Problem-Solving

  • Root cause analysis using 5-Why, Fishbone (6M), Genchi Genbutsu
  • Strong documentation and reporting skills

Soft Skills

  • Cross-functional coordination
  • Attention to detail and time management

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

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Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

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