Walk-In Drive - Injectable Manufacturing - BPharm - 2 To 6 Years

Viatris

Jigani

Sur place

INR 800 000 - 1 200 000

Plein temps

Il y a 3 jours
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Résumé du poste

Viatris is conducting a Walk-In Drive for experienced pharmaceutical professionals with hands-on experience in Injectable Manufacturing Operations and Aseptic Processing. Candidates should be proficient in Vial/PFS handling, sterilization, lyophilization, and in-process checks, with strong GMP and QMS knowledge.

The drive emphasizes regulatory compliance, CAPA, CC, and QA/QC activities, and requires the ability to manage shift operations and manpower effectively across rotation schedules.

Qualifications

  • Hands-on experience in injectable manufacturing operations and aseptic processing.
  • Experience with Quality Management Systems (QMS) including CAPA, Change Control and OOS investigations.

Responsabilités

  • Handle shift operations and manpower management.
  • Participate in regulatory compliance activities and line clearance.
  • Maintain aseptic processing lines and ensure product quality.
  • Prepare and execute standard protocols and documentation.

Connaissances

Aseptic processing
Vial / PFS handling
Sterilization processes
Lyophilization
In-process checks
Shift management
GMP compliance

Outils

TW
Documentum
MES
SAP
GEP

Description du poste

Viatris is conducting a Walk-In Drive for experienced pharmaceutical professionals with hands-on experience in Injectable Manufacturing Operations, Aseptic Processing and Quality Management Systems (QMS).

1. Injectable Manufacturing & Regulatory Knowledge

Candidates must have practical knowledge and experience in the following areas:

  • Aseptic processing activities Vials / Pre-filled Syringes (PFS).
  • Bulk compounding operations.
  • Sterilization processes.
  • Vial washing and depyrogenation.
  • Lyophilization process.
  • Terminal sterilization process.
  • Infusion bag processing activities.
  • In-process checks and line clearance activities.
  • Handling of shift operations and manpower management.
2. Quality Management System (QMS)

Knowledge and experience in the following QMS activities are essential:

  • Preparation of Quality Risk Management (QRM).
  • Incident reporting and investigation.
  • OOL and OOS investigations.
  • Change Control (CC) and Corrective and Preventive Actions (CAPA).
  • Preparation and execution of protocols.
  • CAPA closure reports and documentation.
3. Computer Proficiency

Candidates should have working knowledge of the following systems:

  • TW
  • Documentum
  • MES
  • SAP
  • GEP
4. Other Requirements
  • Candidates must be willing to work in rotational shifts.
  • Good understanding of injectable manufacturing processes and regulatory compliance.
  • Ability to handle shift activities and manpower effectively.
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