Job Summary:
The Document Control Specialist role involves the day-to-day management of site GMP documentation, including coordination, review and management of site control of GMP documents, document changes, distribution of new documents, archiving of quality records, and preparation of quality system records.
This position requires excellent attention to detail, communication (oral & written) and interpersonal skills, with ability to handle multiple tasks in a fast-paced environment, strong organisational and time management skills, and experience working with various IT systems and software packages.
About the Role:
In this role, you will be responsible for ensuring compliance with regulatory requirements and company policies by managing and controlling documents throughout their lifecycle. You will work closely with cross-functional teams to implement document control processes and ensure seamless integration with existing workflows.
Key Responsibilities:
1. Manage and maintain accurate and up-to-date records of site control of GMP documents
2. Coordinate and review document changes, updates, and revisions
3. Distribute new documents and notify relevant stakeholders
4. Architect and maintain a centralized document repository
5. Prepare quality system records and reports as required
Requirements:
To succeed in this role, you will need:
Skill Requirements:
6. Bachelor's degree in a Science related discipline
7. Experience within a pharmaceutical/medical device company desirable but not essential
8. Certification in Document Management or equivalent experience
About Us:
We offer a dynamic and supportive work environment that fosters growth and development. Our team is passionate about delivering high-quality products and services that meet the needs of our customers. If you are a motivated and organized individual with excellent communication skills, we encourage you to apply for this exciting opportunity!