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.

At Anter Consulting, we offer bespoke strategic consultation. We promise unrivalled market knowledge and an extensive network of exceptional candidates.

We focus on delivering tailored solutions, through attentive consultancy services for your team, and finding the right people for your business.