In-Process Quality Assurance Specialist

5 days ago

Solapur, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 40,00,000

Job Title:

In-Process Quality Assurance Specialist

Job Description:

We are seeking a detail-oriented and analytical In-Process Quality Assurance Specialist to join our team. The successful candidate will be responsible for reviewing and approving batch manufacturing records, ensuring completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.

The ideal candidate will have in-depth knowledge of sterile injectable manufacturing processes and aseptic techniques. They will also possess expertise in validation methodologies and regulatory guidelines (US FDA, cGMP).

The specialist will be responsible for resolving discrepancies or missing documentation before batch release, coordinating with on-site teams. They will also review electronic in-process control data, critical process parameter logs, and environmental monitoring results.

Responsibilities:

  1. Review and approve batch manufacturing records, ensuring completeness, accuracy, and compliance with cGMP, SOPs, and regulatory requirements.
  2. Resolve discrepancies or missing documentation before batch release, coordinating with on-site teams.
  3. Review electronic in-process control data, critical process parameter logs, and environmental monitoring results.
  4. Verify product label templates, proofs, and electronic versions for accuracy against specifications and regulatory standards.

Requirements and Qualifications:

  • Detail-oriented and analytical mindset.
  • Excellent problem-solving skills and effective communication.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in QMS tools and software.

Benefits:

This role offers the opportunity to work with a dynamic team, contribute to the success of the organization, and grow professionally. We offer competitive compensation and benefits packages.

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