Urgently Required Assistant Manager Production (Injectable)

Kilitch Drugs

Navi Mumbai

On-site

INR 600,000 - 900,000

Full time

8 days ago
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Job summary

Kilitch Drugs in Navi Mumbai seeks an experienced supervisor for sterile/injectable manufacturing operations. The role ensures compliance with cGMP, WHO and USFDA norms and oversees aseptic processing, sterile filling and lyophilization.

You will review BMR/BPR, maintain documentation, manage cleanroom operations and audit readiness, and coordinate with QA, QC and Engineering to handle deviations, CAPA and investigations.

Qualifications

  • Coordinate with QA, QC, and Engineering teams to ensure smooth operations.
  • Handle deviations, CAPA, and investigations to drive quality improvements.
  • Strong knowledge of aseptic practices and regulatory audits to comply with norms.
  • Good team handling skills to manage cross-functional teams.

Responsibilities

  • Oversee sterile / injectable manufacturing operations
  • Ensure compliance with cGMP, WHO, USFDA norms
  • Handle aseptic processing, sterile filling, lyophilization
  • Review BMR/BPR and maintain documentation
  • Manage cleanroom operations and audit readiness

Skills

QA coordination
Team leadership
Aseptic practices
Regulatory audits
CAPA investigations

Job description

  • Oversee sterile / injectable manufacturing operations
  • Ensure compliance with cGMP, WHO, USFDA norms
  • Handle aseptic processing, sterile filling, lyophilization
  • Review BMR/BPR and maintain documentation
  • Manage cleanroom operations and audit readiness
Required Candidate profile
  • Coordinate with QA, QC, Engineering teams
  • Handle deviations, CAPA, and investigations
  • Strong knowledge of aseptic practices & regulatory audits
  • Good team handling skills
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