Job Description
We are seeking a highly skilled Quality Assurance Documentation Specialist to join our team. As a Quality Assurance Documentation Specialist, you will be responsible for coordinating, reviewing, and managing GMP documents.
Your primary duties will include:
* Coordinating with the Quality Systems Owner to manage document control.
* Performing detailed reviews of document changes prior to final approval.
* Distributing new documents and retrieving old documents (internally & externally).
* Archiving quality records.
* Assisting in the preparation, revision, and review of quality system records.
* Providing quality-related training applicable to your job role.
* Managing incident reports, CAPA, change control, and customer complaints systems as required.
* Preparing KPI/Management review data on a weekly/monthly/quarterly/annual basis as needed.
Required Skills and Qualifications
To be successful in this role, you will need to have:
* A minimum of a Bachelor's degree in a Science-related discipline.
* Experience within a pharmaceutical or medical device company is desirable but not essential.
* Excellent attention to detail, communication (oral & written) and interpersonal skills.
* The ability to handle multiple tasks in a fast-paced environment with strong organisational and time management skills.
* Experience working with various IT systems and software packages with a strong working knowledge of Microsoft Office.
* The ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.
* The ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.
Benefits
We offer a range of benefits, including:
* Excellent career progression opportunities.
* Work-life balance initiatives.
* A bonus scheme.
* Health insurance.
* Pension.
About Us
We are committed to building a diverse, inclusive, and authentic workplace. If you're excited about this role but your past experience doesn't fully align with every requirement, we encourage you to apply.