Gmp Document Administrator

6 months ago

Glasgow, United Kingdom Centre for Process Innovation Full time

**About **CPI**:
CPI helps make great ideas and inventions a reality. We’re a team of intelligent people using advances in science and technology to solve the biggest global challenges in healthcare and sustainability.

Through our incredible people and innovation infrastructure, we collaborate with our partners in industry, academia, government, and the investment community to accelerate the development and commercialisation of innovative products.

From health technologies and pharmaceuticals to sustainable food and materials innovations, we turn the entrepreneurial spirit and radical thinking of our people and partners into incredible impact that makes our world a better place.

**Why this role is important for CPI’s work**:
CPI is currently recruiting for an exciting opportunity for a GMP Document Administrator to join its expanding quality team.

Quality is a key foundation of our business and through effective quality management, CPI will continue to add value to the company and help achieve its business goals.

The focus of this role is to establish and maintain document management processes across our facilities, promoting and integrating quality into every aspect of our business. In this role, you will perform a variety of tasks relating to GMP documentation management, including but not limited to, the drafting, issuance, and review of various document types such as logbooks, policies, SOPs and technical documents and continued improvement of the CPI Medicines Manufacturing Innovation Centre (MMIC) quality management system and expansion to the Oligonucleotide Manufacturing Innovation Centre of Excellence to meet GMP requirements.

Key tasks in the GMP Document Administration role will include (but are not limited to the below), please download the job description for full details available on the CPI careers page:

- Embrace and role model the desired behaviours to exemplify our Company values, promoting an ethical, positive company culture.
- To maintain consistent and documented compliance with all relevant Safety, Health and Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements.
- Document controller activities for all GMP controlled documentation including policies, SOPs and protocols.
- Control, issue, reconciliation, and archive of GMP manufacturing documentation within the quality, technical and operational areas.
- Supporting the Quality team with any other requirements as required.

**The person we are seeking**:
**Essential**:

- A minimum of 5 National 5 or GCSEs grade A‑C (9 - 4), including English and Mathematics.
- Experience using paper and electronic document management systems.
- Strong attention to detail with a thorough approach.
- The ability to prioritise, be extremely organised and methodical.
- Excellent interpersonal and communication skills to establish good relationships across all functions and at all levels within the organisation in order to promote the use of established tools and systems for documentation.
- Ability to work in fast paced environment, flexibility to adjust with moving priorities and ensuring attention to detail remains first class.

Desirable:

- Document management expertise and experience of operating within a quality management system.
- Experience in the use and implementation of Electronic Document Management systems and QMS.
- Experience in pharmaceutical/medical device industry with understanding of GMP principles.

**What does **CPI** offer you?**:
At CPI, we offer a wide range of benefits to our employees, this includes:

- Up to 36 days holiday, including bank holidays - Plus a holiday purchasing scheme
- Generous pension scheme
- Life assurance and accident insurance schemes
- Flexible working
- Learning and Development Opportunities
- Free parking

Find out more about our culture and benefits.

**Additional information**:
CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.

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