Quality Assurance Officer – BDD Pharma Ltd. 09 May 2023
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.
Location: BioCity Scotland, Bo’Ness Rd, Newhouse ML1 5UH and Bio-Imaging Centre, Medical Block, Glasgow Royal Infirmary, Glasgow, G4 0SF Hybrid home and office working
Contract: Full time / part time, Permanent
Reports: QA Compliance Manager
BDD Pharma Background
BDD Pharma is a rapidly growing research focused drug delivery company based in Glasgow with clinical trial, formulation development and GMP manufacturing capabilities. We specialize 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.
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QA documentation review, including but not limited to validation plans and reports, completed/superseded logbooks, controlled labels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
This is a full time, permanent role with the opportunities for hybrid working following completion of training. Standard hours will be 9-5 or 8-4 Monday to Friday (37.5 hours a week). Part time opportunities are also available for the right candidate.
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:
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
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)
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
Private medical insurance
Monday to Friday
Work Location: In person / Home working