Quality Assurance Specialist

5 days ago

Tirupati, Andhra Pradesh, India beBeeSterileInjectables Full time ₹ 15,00,000 - ₹ 20,00,000

Job Opportunity Overview

We are seeking a skilled professional to join our team in ensuring the quality of sterile injectable manufacturing processes. This key role involves reviewing and approving batch records, coordinating with on-site teams to resolve discrepancies, and reviewing electronic data for in-process control and product label templates.

Additionally, you will be responsible for compiling and analyzing data for Annual Product Quality Review reports, identifying trends or recurring issues, and preparing remote review summaries for cross-functional teams. Furthermore, you will review and assess electronic change control proposals, conduct remote reviews of deviation reports and root cause analyses, and track deviation trends for periodic reporting.

You will also ensure remote audit readiness by reviewing documentation for alignment with cGMP, US FDA, and other applicable regulatory requirements. Moreover, you will participate in virtual inspections and audits, providing requested documentation and clarifications.

Key Qualifications and Skills:

  • Expertise in sterile injectable manufacturing processes and aseptic techniques.
  • Knowledge of 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.

Educational Requirements:

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

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