Archive Officer / Librarian

Position: Archival In-charge Vaccine Manufacturing Unit

Department: Quality Assurance / Quality Systems

Experience Required: 3 – 4 Years (GMP / Pharmaceutical / Biotech / Vaccine domain)

Location: Manufacturing Site

About the Role

Experienced Archival In-charge to manage GxP documentation and record control in a regulatory compliant vaccine manufacturing environment. The role ensures readiness for WHO, FDA and national regulatory audits by maintaining integrity, traceability, and secure storage of critical records.

Key Responsibilities

Document & Record Control

• Receive, verify, classify, and archive batch records, QC data, validation documents, calibration/qualification records and supporting GMP documentation.
• Maintain document indexing, master archive registers and access logs.
• Control issuance, retrieval and tracking of documents requested by departments and auditors.

Archival Room & Facility Management

• Maintain archive room conditions as per regulatory expectations (restricted access, temperature/humidity control, pest control).
• Periodic inspection of archived files for condition, completeness and traceability.
• Ensure segregation of active, semi-active, inactive records and disposal files.

Regulatory & Audit Readiness

• Provide archived records during internal and external audits.
• Ensure documentation complies with regulatory requirements.
• Verify adherence to defined record retention timelines.

Electronic Document Management

• Assist in scanning, indexing and digital storage of documents in EDMS.
• Support user access control, retrieval, backup validation and data migration activities.

SOPs, Training & Compliance

• Prepare/update SOPs related to archiving and document control.
• Train departments on record submission, documentation practices and archival requirements.

Record Disposal & Security

• Coordinate secure destruction of expired records as per retention policy.
• Maintain destruction logs and confidentiality.

Qualifications & Experience

• Education:

  B.Sc / M.Sc / B.Pharm / M.Pharm (Life Sciences preferred).

• Experience:

  3–4 years in pharmaceutical / vaccine / biotech documentation or QA archival management.
• Knowledge of GMP principles and ALCOA+ documentation compliance.

Skills & Competencies

• Strong record management skills
• Good coordination, tracking and retrieval discipline
• Familiarity with GxP expectations of vaccine manufacturing
• Working knowledge of MS Office / EDMS
• Attention to detail, confidentiality, accountability