Job Opportunity - Quality Assurance Manager
Salary:
Competitive / Based On Experience
Discipline:
Active Pharmaceutical Ingredients
Reference:
MER_****
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 who service a niche, fast-growing sector within the pharmaceutical 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.
This role come with ample opportunity for true opportunity for growth.
The Role
You will work alongside production and support QC as the manager of a Quality Assurance team.
You will 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 knowledge and skills will contribute towards the goals and objectives of the QA team and wider company team.
Your focus and ability to meet team targets will help in completing critical deliverables.
You you will support establishing consensus between teams to ensure quality and optimisation.
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 and develop plans for work activities within QA Department.
Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
Suggest improvements and conduct 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 elevate issues as appropriate to the Quality Assurance Lead in a timely manner.
Documentation Responsibilities
Develop systems and then maintain regulatory compliance in accordance with current Good Manufacturing Practices.
Provide Quality Review and oversight of site documentation related to the operation of manufacturing facility/laboratory to ensure compliance.
Support the development, review and approval of validation documents Process, cleaning & method validation.
Develop annual product quality review plan and complete annual reviews as per schedule.
Provide quality oversight of purchase material qualification activities and GMP service providers.
Support audits of suppliers and GMP service providers including providing vendor information to RQA and performing vendor audits.
Prepare and approve quality agreements with applicable suppliers.
Review and approve master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing.
Qualifications
5+ years' experience in a Quality Assurance role.
Experience and knowledge of cGMP environments and the applicable GxP regulations and standards.
Proactive approach and strong critical thinking skills.
Must be able to work in a team environment, lead a QA team and liaise with interdepartmental teams.
Excellent working knowledge of Microsoft Excel and Word.
Experience in electronic quality management systems.
Relevant pharmaceutical experience.
Experience of API manufacture.
Willing to lead by example.
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:
******
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
****** or through filling out the form.
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