Jr Executive, Quality Assurance

Amneal Pharmaceuticals LLC; Sanand; Vor Ort; INR 600.000 - 900.000; Vollzeit

Zusammenfassung

Amneal Pharmaceuticals LLC in India is seeking a QA professional to manage the Document Management System (DMS), Training Management System (TMS), and routine QA compliance activities. The role requires solid GMP knowledge and strong documentation skills.

The candidate will maintain controlled documents, track SOPs and training records for all employees, and coordinate with cross-functional teams to ensure data integrity and regulatory compliance at the Sanand site.

Qualifikationen

• Solid GMP knowledge and data integrity are required.
• Strong documentation and record-keeping skills are essential.
• Excellent written and verbal communication, and cross-functional coordination.

Aufgaben

• Manage DMS: review, issuance, archival of controlled documents.
• Maintain the document cell: storage, access control, retrieval.
• Track document inventory and manage revisions of SOPs and logs.
• Maintain training matrices and verify training records for all employees.
• Coordinate with cross-functional teams to close document and training gaps.
• Ensure compliance with GMP, GDP, and ALCOA+ requirements.

Kenntnisse

GMP knowledge

Data integrity

Communication

Coordination

Documentation

Ausbildung

B.Pharm / M.Pharm / M.Sc (Biotech/Microbiology or related field)

Jobbeschreibung

Job Summary

QA professional to manage Document Management System (DMS), Training Management System (TMS), and routine QA compliance activities. The role requires solid GMP knowledge and strong documentation skills.

Key Responsibilities

• Manage controlled documents in the DMS (review, issuance, archival).
• Maintain the document cell, ensure proper document storage, controlled access, and easy retrieval.
• Track document inventory (SOPs, formats, logbooks) and ensure timely issuance and replacement of revised versions.
• Maintain training matrices and verify training records for all employees, including new joinees.
• Coordinate with cross-functional teams to resolve document and training gaps.
• Ensure compliance with GMP, GDP, and ALCOA+ requirements.

Skills Required

• Strong understanding of GMP and data integrity.
• Excellent communication, coordination, and documentation skills.

Education

• B.Pharm / M.Pharm / M.Sc (Biotech/Microbiology or related field)

B.Pharm / M.Pharm / M.Sc (Biotech/Microbiology or related field)

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