About Kent-Athlone Pharma Group
With sites in the UK and Ireland, Kent-Athlone Pharma Group manufactures and distributes speciality pharmaceuticals across the UK, Ireland, and international markets.
Our portfolio of products is diversified across multiple therapeutic areas with for example a focus on analgesics, oncology, ophthalmology, hospital injectables and anti-infectives.
With a strong pipeline of new product development projects and potential M&A opportunities, the company is experiencing a period of rapid growth, and this trajectory is expected to continue.
Kent-Athlone Pharma Group was created from a PLC divestment to an experienced Management Team supported by Duke Street Partners who are a leading European Private Equity Group.
In 2022 a revised 5-year strategy, growth plan and additional investment was agreed with the Board, driven by a strong focus on Business Development.
The Person
We are looking for someone dynamic who wants to work as part of a wider team to deliver excellence. You must be:
Passionate about what you do and wanting to make a difference.
Organised and a self-starter, able to scope projects and drive initiatives.
Logical and systematic in the approach to your work, delivering a high level of accuracy and within agreed timeframes.
Proficient in the use of Excel and able to analyse and manipulate data.
Able to work in PowerPoint, creating quality presentation materials.
Able to prioritise and quickly adapt to changing and competing priorities.
Able to demonstrate excellent written and verbal communication skills.
Someone who is able to communicate confidently with a range of different stakeholders both internally and externally and at different levels.
Able to self-manage with a positive, can-do approach.
A strong team player who is committed, collaborative and has a passion for delivering excellence.
Someone who thrives in a fast-paced environment and able to take responsibility and ownership.
Someone who is wanting to learn and develop professionally.
Role duties and responsibilities
The key responsibilities of the QA Compliance Officer at Kent-Athlone Pharma Group include, but are not limited to:
Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives for assigned products.
Review of internal documentation to ensure compliance with license details and relevant guidelines and directives
Track and investigate any assigned investigations and complete CAPA actions to agreed timeframes.
Review and approval of Third Party CMO Master Batch Records (Batch Manufacturing & Packing records, Validation/Stability Protocols and Report, Finished Product Specifications and End of Shelf-Life specifications) for assigned products.
Prepare and Manage Quality Metrics and tracking reports on a weekly/monthly basis (Open Items/QRG/Audit Steering) and record all minutes and follow up actions (prepare relevant slides/reports).
Complete Annual compliance reviews of Third Party CMOs manufacturing process, specifications, test methods, GMP licence, and validation status, Stability reporting and packaging specifications for compliance to the MA.
Support maintaining and improving the Quality Management Systems supporting the Pharma QMS and CMO activity and ensuring that all aspects of the Quality Management Systems are up to date with Current GMP requirements.
Assist as required during internal/external customers and competent authority audits.
Review change control for assigned products and bring changes to the change review board (CRB) as necessary.
Develop and maintain familiarity with applicable legislation, guidelines and current industry practice that impact GMP, the QMS and validation activities.
Assist with the coordination and planning of API, Contract manufacturer and internal audits (Via Audit steering meetings).
Track and review CMO Product Quality Reports (PQRs) for assigned products and ensure that these are consistently completed fully and on time.
Complete risk assessments as required for key processes changes, new regulations and as required per NCR/CAPAs.
Skills and Experience (E: Essential, D: Desirable)
Whilst industry experience is not essential, the desire to stand out in a fast-paced environment is. You must have:
Experience and knowledge of good manufacturing practises and associated regulations.
A working knowledge of quality systems requirements, HPRA, MHRA, EU regulations and ICH guidelines as they relate to Quality Assurance.
IT Skills in Microsoft word and excel.
Education
Third Level qualification preferably in a scientific discipline
Other Requirements
A valid Passport* as some European travel may be necessary for external events, trade shows, meetings, conferences, etc.
Pay: €30,000.00-€35,000.00 per year
Benefits:
- Additional leave
- Bike to work scheme
- Company events
- Company pension
- Employee assistance program
- Flexitime
- On-site parking
- Sick pay
- Wellness program
- Work from home
Work Location: Hybrid remote in Roscommon, County Roscommon
