Quality Assurance Specialist

5 days ago

Vizag, Andhra Pradesh, India beBeeQualityProfessional Full time ₹ 1,04,000 - ₹ 1,30,878

Key responsibilities of this role include:

  • Review batch manufacturing records and batch packing records for completeness and compliance with Good Manufacturing Practices.
  • Develop, review, and approve standard operating procedures and specifications.
  • Ensure that all documentation meets pharmacopeial standards and regulatory requirements.

Batch release is a critical function of this position. Responsibilities include:

  • Evaluate and approve batch documentation for the release of raw materials, intermediates, and Active Pharmaceutical Ingredients.
  • Resolve deviations, change controls, and out-of-specification results prior to batch release.

Audits and inspections are an integral part of this role. Key responsibilities include:

  • Participate in internal audits, vendor audits, and regulatory inspections.
  • Implement corrective actions based on audit findings.
  • Maintain audit readiness and ensure compliance with all regulatory requirements.

This position requires strong technical skills, including:

  • Knowledge of Good Manufacturing Practices and regulatory guidelines.
  • Understanding of quality systems, such as deviation management and document control.
  • Experience with process validation, equipment qualification, and analytical method validation.

Soft skills, such as attention to detail and effective communication, are also essential for success in this role.

This is an office and manufacturing site-based role with occasional exposure to production environments.

Key performance indicators for this position include:

  • Timeliness and accuracy of documentation review and approval.
  • Compliance with GMP and regulatory requirements during audits and inspections.
  • Effective resolution of deviations and implementation of corrective actions.
  • Training effectiveness and adherence to SOPs by team members.

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