QA Officer OSD Documentation

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QA Officer OSD Documentation

work outline icon2 - 3 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Milan Laboratories India Private Limited

time outline iconBharuch, Gujarat, India

Posted on 04-10-2024

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2 Vacancies

Description

  • Quality Compliance: Ensure that all production processes and products comply with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements.
  • Batch Record Review: Review and approve batch manufacturing records (BMR) and batch packaging records (BPR) to ensure accuracy, completeness, and compliance with quality standards before product release.
  • Deviation & CAPA Management: Identify, document, and investigate deviations, non-conformities, and out-of-specification (OOS) results, and initiate corrective and preventive actions (CAPA) to resolve them.
  • Internal Audits & Inspections: Conduct internal audits of production, warehouse, and other departments to ensure compliance with quality standards, and support external audits by regulatory bodies and clients.
  • SOP Development & Training: Assist in developing and updating SOPs, work instructions, and guidelines, and provide training to staff to ensure consistent adherence to quality procedures.
  • Quality Documentation: Maintain accurate and up-to-date quality documentation, including change control, deviations, CAPAs, and audit reports, ensuring traceability and compliance.
  • Quality Control Collaboration: Collaborate with the QC department to resolve quality issues, participate in quality improvement initiatives, and ensure timely resolution of quality-related concerns.
  • Product Testing & Release: Oversee and verify product testing processes, ensuring that only products meeting the required specifications are released for sale or distribution.

Category

Pharmaceuticals

Functional Area

Pharma Quality Assurance (QA)

Key Skills

CommunicationCritical CarePositivityproblam solving

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