Quality Assurance Officer

2 weeks ago

Glasgow, United Kingdom BDD Pharma Full time

An exciting opportunity has arisen within BDD Pharma for a QA Officer to join the expanding team at our research site in Biocity. This is a pivotal role within the QA team, where you will support our QA Compliance Manager and Head of Quality in the maintenance of BDD's QMS.

**Key responsibilities are as follows**:

- Document review and approvals within the Quality System
- Document control activities such as issue and archive within the e-QMS
- Prepare induction documentation for new hires
- Maintaining lists and databases within the Quality System
- Issue of controlled documentation such as equipment/laboratory logbooks, GMP manufacturing records, equipment qualification documentation,
- QA documentation review, including but not limited to validation plans and reports, completed/superseded logbooks, controlled labels
- Review of documentation to monitor compliance with good documentation practices
- Review of vendor approval requests and distributing supplier questionnaires
- Provide Support in client or regulatory audits
- Support the Quality Compliance Manager with internal audits
- Review and closure of CAPA, deviation, Change Control
- General administrative duties such as document scanning and filing, minute taking, presentation preparation, communications with the wider teams
- Trending of Quality Issues for metric reporting

We are looking for a confident, driven individual with a care for detail who shares our enthusiasm for delivering on customer excellence and our passion for research. In return you will join a fast-paced, start-up like environment where initiative and a questioning mind is valued. There are opportunities for growth for an ambitious person who would like to develop within a GXP environment.

**The following skills and experience are required**:
Essential
- Bachelors degree or equivalent in scientific discipline
- At least 2 years GMP or GCP auditing or quality experience within a pharmaceutical/clinical trial environment
- Able to work responsibly and communicate effectively with colleagues, clients, auditors, visitors, external companies
- Meticulous attention to detail in recording data and ability to act in a timely and efficient manner.
- Full driving licence

Desirable
- Experience of using QPulse
- Demonstrated ability to handle multiple competing priorities and utilise resources effectively
- Ability to work independently
- Strong communication skills (written and verbal)

**Company Overview**

BDD Pharma is rapidly growing research focused drug delivery company based in Glasgow with clinical trial, formulation development and GMP manufacturing capabilities. We specialise in the development of novel pharmaceutical products and undertaking bespoke clinical services which help our customers better understand how their drug delivery systems perform. When you join BDD, you become part of a team dedicated to supporting the development of new medicines and improving the health of others.

**Why join BDD?**
- We offer a competitive salary and benefits package which includes private healthcare through Vitality, a generous pension scheme and access to our employee assistance programme with Health Assured.
- You will be part of a young workforce with an open and transparent culture which is maintained throughout the business.
- We offer a unique working environment as a combined CRO and investigative site with integrated formulation development, GMP manufacturing and clinical research services. This means that every day is different. Working at the cutting edge of early-stage drug development and clinical research provides a challenging environment with continued learning.
- The opportunity to work on a variety of projects across a range of therapeutic areas, helping to shape the development of new medicines with some of the world’s biggest pharmaceutical companies and those at the forefront of technological advances.

**Job Types**: Full-time, Part-time

**Benefits**:

- Company pension
- Private medical insurance
- Wellness programme

Schedule:

- Monday to Friday

Work Location: In person

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