Industry: Pharmaceutical / Life Sciences
Department: Quality Assurance (QA) / Regulatory Affairs
We are seeking a detail-oriented and organized Document Control Specialist to support documentation management activities in a regulated pharmaceutical environment. This entry-level role is ideal for candidates with a background in pharmacy, life sciences, biotechnology, or related fields who are looking to start their career in Quality Assurance or Regulatory Affairs.
Key Responsibilities:Manage, review, track, and maintain controlled documents including SOPs, batch records, validation protocols, and regulatory submissions.
Ensure compliance with regulatory requirements such as Food and Drug Administration (FDA) , European Medicines Agency (EMA) , and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
Maintain document control systems (electronic and/or paper-based).
Assign document numbers and ensure proper version control.
Archive and retrieve documents as required.
Support internal and external audits by providing documentation.
Coordinate document review and approval workflows.
Ensure compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
Assist in training employees on documentation procedures.
Maintain logs for change controls, deviations, and CAPA records.
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