Sterile Injectable Manufacturing Specialist

4 days ago


Malappuram, Kerala, India beBeeQuality Full time ₹ 30,00,000 - ₹ 40,00,000

Seeking a Quality Assurance Professional with Sterile Injectable Manufacturing Expertise

Job Description:

As a key member of our team, you will be responsible for ensuring the quality and integrity of sterile injectable manufacturing processes.

  • Review and approve batch records to ensure completeness, accuracy, and compliance with regulatory requirements.
  • Coordinate with cross-functional teams to resolve discrepancies and ensure timely documentation.
  • Review electronic data for trends and recurring issues.

Key Responsibilities:

  • Verify product label templates for accuracy against specifications and regulatory standards.
  • Compile and review electronic data for Annual Product Quality Review (APQR) reports.
  • Assess and approve change control proposals via QMS software.

Required Skills and Qualifications:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.
  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines.

Benefits:

  • Opportunity to work with a dynamic team in a fast-paced environment.
  • Chance to develop expertise in sterile injectable manufacturing and quality assurance.

Others:

  • Participate in virtual inspections and audits.
  • Provide remote guidance to manufacturing site teams.


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