Senior Sterile Manufacturing Specialist

1 week ago

Nellore, Andhra Pradesh, India beBeeManufacturing Full time ₹ 15,00,000 - ₹ 20,00,000

Ensuring Manufacturing Excellence: A Comprehensive Overview

  • The ideal candidate will review and approve executed Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs), guaranteeing completeness, accuracy, and compliance with cGMP and regulatory requirements.
  • They will coordinate with on-site teams to resolve discrepancies or missing documentation before batch release, promoting a seamless manufacturing process.
  • The selected professional will review electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site, identifying areas for improvement.
  • They will verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards, ensuring conformity.
  • This role involves compiling, reviewing, and analyzing electronic data for Annual Product Quality Review (APQR) reports, identifying trends or recurring issues.
  • The candidate will review, assess, and approve electronic change control proposals via QMS software, evaluating potential impacts on validation and processes.
  • They will conduct remote review of deviation reports, root cause analyses, and corrective action proposals, tracking deviation trends for periodic reporting.
  • The successful candidate will approve CAPA plans in the QMS system, ensuring they address identified issues with measurable effectiveness criteria.
  • They will review and approve Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation reports submitted from the site, ensuring thorough root cause analysis and effective preventive measures.
  • This role requires ensuring remote audit readiness by reviewing documentation for alignment with cGMP and regulatory requirements.
  • The selected professional will participate in virtual inspections and audits, providing requested documentation and clarifications.
  • They will maintain close coordination with on-site QA personnel to ensure timely resolution of documentation and compliance issues.

Required Skills and Qualifications:

  • Expertise in sterile injectable manufacturing processes and aseptic techniques.
  • In-depth knowledge of 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.

Education and Qualifications:

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

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