Sterile Manufacturing Process Validation Expert

4 days ago

Meerut, Uttar Pradesh, India beBeeSterile Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Title:

Sterile Manufacturing Process Validation Expert

Description:

We are seeking an expert in sterile injectable manufacturing processes to join our team. The ideal candidate will have in-depth knowledge of aseptic techniques and validation methodologies, as well as expertise in regulatory guidelines such as US FDA and cGMP.

Responsibilities:

  • Aseptic Process Integrity: Prepare, review, and approve validation protocols and reports for media fill studies, ensuring the quality and integrity of sterile injectable manufacturing processes.
  • Validation Specialist: Analyze remote media fill results, identify deficiencies, and recommend corrective or preventive actions.
  • Area Qualification: 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.
  • Equipment Qualification: Prepare and review periodic requalification protocols, data, and environmental monitoring summaries for compliance with cGMP and regulatory requirements.
  • Installation Qualification: Prepare, review, and approve Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for manufacturing equipment.
  • Cleaning Validation: Prepare and review cleaning validation protocols and reports to ensure adequacy, compliance, and suitability for product changeover.
  • Process Validation: Prepare, review, and approve process validation protocols, data, and reports to confirm process robustness and consistency in product quality.
  • Validation Master Plan: Maintain and update the Validation Master Plan (VMP), ensuring alignment with regulatory expectations and site needs.

Requirements:

  • Expertise in sterile injectable manufacturing processes and aseptic techniques.
  • 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.
  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

Benefits:

This is a rewarding opportunity for someone who wants to make a difference in the field of sterile injectable manufacturing. If you are passionate about delivering high-quality products, we encourage you to apply.

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