Sterile Manufacturing Specialist

4 days ago

Bellary, Karnataka, India beBeeQuality Full time ₹ 25,00,000 - ₹ 30,00,000

Job Title: Quality Assurance Specialist

Our ideal candidate will have a proven track record of ensuring the highest standards of quality in manufacturing processes.

Key Responsibilities:

  • Prepare, review and approve validation protocols and reports for media fill studies, ensuring aseptic process integrity.
  • Analyze remote media fill results, identify deficiencies and recommend corrective or preventive actions.
  • Prepare and review area qualification protocols and reports for classified manufacturing areas (Grade A–D) based on environmental monitoring and qualification data from the site.
  • Prepare and review periodic requalification protocols, data and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Prepare, review and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Support and participate in Factory Acceptance Test (FAT) execution for equipment at vendor locations (onsite when required, otherwise through live remote connection), ensuring test protocols are followed and results are documented.
  • Prepare and review utility qualification documentation, including HVAC, Water for Injection (WFI), and compressed air system validation.
  • Prepare, review and approve cleaning validation protocols and reports to ensure adequacy, compliance and suitability for product changeover.
  • Prepare, review and approve process validation protocols, data and reports to confirm process robustness and consistency in product quality.

Required Skills and Qualifications:

  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in QMS tools and software.

Benefits:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology or related field.

We are seeking a highly skilled Quality Assurance Specialist with 10-15 years of experience in Quality Assurance. In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques is essential.

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