Quality Assurance Specialist

3 days ago


Hubli, Karnataka, India beBeeQuality Full time ₹ 30,00,000 - ₹ 40,00,000
Job Title: Quality Assurance Specialist

We are seeking a Quality Assurance Specialist to join our team. The ideal candidate will have a strong understanding of quality management principles and be able to apply them in a manufacturing environment.

About the Role

The Quality Assurance Specialist will be responsible for ensuring the quality and compliance of manufacturing processes. This includes reviewing and approving executed batch manufacturing records, coordinating with on-site teams, reviewing electronic in-process control data, and verifying product label templates.

The successful candidate will have excellent analytical and problem-solving skills, as well as effective communication and documentation skills. They will also be proficient in QMS tools and software.

Key Responsibilities
  • Reviewing and approving executed batch manufacturing records (BMRs) and batch packaging records (BPRs)
  • Coordinating with on-site teams to resolve discrepancies or missing documentation
  • Reviewing electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results
  • Verifying product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards
  • Compiling, reviewing, and analyzing electronic data for Annual Product Quality Review (APQR) reports
  • Reviewing, assessing, and approving electronic change control proposals via QMS software
  • Conducting remote review of deviation reports, root cause analyses, and corrective action proposals
  • Approving CAPA plans in the QMS system
  • Reviewing and approving Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports
Requirements
  • 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
  • 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

This is an exciting opportunity to work in a dynamic environment and contribute to the success of our organization. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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