QA Specialist Documentation

We are seeking a QA Specialist - Documentation to support GMP document management within a pharmaceutical manufacturing environment. The role involves maintaining controlled documentation, supporting digital documentation initiatives and ensuring records remain accurate, compliant and readily retrievable.

Responsibilities

. Maintain document management processes in accordance with company quality standards and applicable regulatory requirements.

. Support the implementation of electronic logbooks and electronic forms.

. Manage the GMP governance and issuance of paper-bound logbooks and controlled printing of forms.

. Perform document archival and scanning for electronic storage.

. Manage the GxP documentation lifecycle, including document creation, revision and obsolescence.

. Coordinate with departments and subject matter experts to ensure documentation accurately reflects business processes and meets regulatory and quality requirements.

. Review documents for accuracy, completeness, clarity, grammar and consistency with established writing standards.

. Identify and reduce unnecessary duplication within documentation.

. Collect requests for documentation changes, prioritise updates and coordinate their completion.

. Ensure documents undergo regular review and remain current.

. Maintain appropriate document distribution and access controls in accordance with information classification requirements.

. Support internal and external audits and inspections by ensuring required documents are current and readily retrievable.

Requirements

. Minimum 2 years of relevant experience, preferably in Manufacturing, Validation or Quality within the pharmaceutical or biotechnology industry.

. Experience in vaccines and/or biologics manufacturing is preferred.

. Good understanding of pharmaceutical regulations, quality standards, GMP/GxP documentation practices and data integrity requirements.

. Strong attention to detail and the ability to maintain accurate and compliant records.

. A disciplined approach to decision-making, task prioritisation and execution.

. Good communication and interpersonal skills, with the ability to collaborate across departments and promote a quality-focused culture.

. Fluent in spoken and written English.