Manufacturing Quality Specialist

1 day ago

Surat, Gujarat, India beBeeQuality Full time ₹ 30,00,000 - ₹ 40,00,000

Quality assurance specialists play a pivotal role in maintaining high standards of quality and compliance across manufacturing operations.

About the Role
  • This position involves reviewing and approving batch records, packaging records, and electronic control data to ensure accuracy and adherence to regulatory requirements.
  • The specialist will coordinate with on-site teams to resolve discrepancies or missing documentation before batch release.
  • They are responsible for verifying product label templates and specifications against regulatory standards.
  • The individual will compile, review, and analyze data for annual product quality reviews, identifying trends and preparing summaries for cross-functional teams.
  • Additionally, they will review and assess electronic change control proposals, evaluating potential impacts on validation and processes.
  • Conducting remote review of deviation reports, root cause analyses, and corrective action proposals, tracking deviation trends for periodic reporting.
  • The specialist will approve CAPA plans and review closure documentation to confirm adequacy of evidence.
  • Reviewing and approving investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
  • The individual will also ensure remote audit readiness by reviewing documentation for alignment with cGMP and regulatory requirements.
Key Qualifications
  • A degree in Pharmacy, Biotechnology, Microbiology, or a related field is required.
  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques is essential.
  • The ideal candidate will possess expertise in validation methodologies and regulatory guidelines.
  • Strong analytical and problem-solving skills are necessary for success in this role.
  • Effective communication and documentation skills are critical for collaboration and stakeholder management.
  • Ability to manage cross-functional teams and prioritize tasks is also essential.

The successful candidate will be an analytical and detail-oriented professional with excellent communication skills, able to work collaboratively in a fast-paced environment.

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