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Senior Aseptic Process Specialist

3 weeks ago

Thāne, Maharashtra, India beBeeInprocessquality Full time ₹ 15,00,000 - ₹ 20,00,000

Enhance Product Quality with In-Process QA Expertise

This critical role involves evaluating and verifying the accuracy of executed batch manufacturing records (BMRs) and batch packaging records (BPRs) to ensure compliance with current good manufacturing practices (cGMP), standard operating procedures (SOPs), and regulatory requirements.

The In-Process Quality Assurance specialist will collaborate with on-site teams to address discrepancies or missing documentation before batch release, ensuring seamless production processes.

An integral part of this role is reviewing electronic in-process control (IPC) data, critical process parameter logs, and environmental monitoring results uploaded from the site.

In addition, the specialist will verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.

Key responsibilities include compiling, reviewing, and analyzing electronic data for Annual Product Quality Review (APQR) reports, identifying trends or recurring issues, and preparing remote review summaries for cross-functional teams.

The IPQA specialist will also assess and approve electronic change control proposals via QMS software, evaluating potential impacts on validation, processes, and regulatory compliance.

This position demands strong analytical and problem-solving skills, effective communication and documentation skills, as well as proficiency in QMS tools and software.

Key Skills and Competencies:

  • Aseptic Techniques and Sterile Injectables: In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Regulatory Compliance and Validation: Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
  • Analytical and Problem-Solving Skills: Strong analytical and problem-solving skills.
  • Communication and Documentation: Effective communication and documentation skills.
  • Cross-Functional Team Management: Ability to manage cross-functional teams and prioritize tasks.
  • QMS Proficiency: Proficiency in QMS tools and software.

Education and Qualifications:

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