Job Opportunity - Quality Assurance Specialist
Location: Athlone
Job type: Permanent
Salary: Competitive / Based On Experience
Discipline: Active Pharmaceutical Ingredients
Reference: MER_2204
Introduction
Join an exciting new Irish Company researching and producing speciality Active Pharmaceutical Ingredients for global distribution.
Arbutus Innovation Centre is advertising this position on behalf of Mercury Rising Limited, an exciting start-up, servicing a niche, fast-growing global industry. This is an exciting opportunity to work in a fast-paced environment with a small, collaborative and dynamic team of innovators and experienced leaders.
The Role
Reporting to the Quality Assurance Manager you will support the introduction of quality systems and evaluate and review commercial batches of APIs. You will make sure that batches and process documents match the specifications based on established sampling and statistical process control procedures.
You will help identify possible deviations from established standards, in the manufacturing and packaging of Active Pharmaceutical Ingredients. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies. Your focus and ability to meet team targets will help in completing critical deliverables.
The Location:
The new API manufacturing site is within Arbutus Innovation Centre, a pharmaceutical incubator located in Monksland, on the west side of Athlone.
Role Responsibilities:
Contribute to the completion of projects, manage own time to meet agreed targets.
Accurately communicate Supply/Operational needs.
Suggest improvements and carry out continuous improvement activities.
Assess a wide range of Change Control activities to determine potential Quality and cGMP impacts.
Investigate, document Quality Assurance related deviations and escalate issues as appropriate to the Quality Assurance Lead in a timely manner.
Documentation Responsibilities:
Support the maintenance of regulatory compliance in accordance with cGMP requirements.
Maintain documentation related to the operation of manufacturing facility/laboratory to ensure compliance.
Support in the development, review and approval of validation documents Process, cleaning & method validation.
Provide quality oversight and document support related to the purchase activities and GMP contractors/suppliers.
Support audits of suppliers and GMP service providers
Performing vendor audits
Support the preparation of quality agreements with applicable suppliers
Support the approval of master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
Essential Requirements
Third level qualification in scientific discipline.
Preferable to have at least 1-2 years’ experience in a GMP and/or GDP environment.
Must be able to work in a team environment
Strong attention to detail
Excellent working knowledge of Microsoft Excel and Word
What We Offer
Strong Opportunity for growth
Opportunity to learn and grow across departments
Flexible working options
Additional Information
To be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position.
Equal Opportunity Employers
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Arbutus Innovation Centre and its client companies are committed to celebrating this, in all its forms. We strive to build a culture that encourages, supports and empowers our employees.
Competitive Salary & Benefits:
Interested candidates should submit an updated CV and cover letter to:
careers@arbutus.ie
IRELAND
Daneswell Business Park
Monksland, Athlone
Co. Roscommon
Republic of Ireland
Contact Us
If you have any questions related to this job opportunity or would like further information please contact us via careers@arbutus.ie or through filling out the form.
