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Contracts Consultant chloe.slingsby@peglobal.net 0860200448
PE Global are currently recruiting for a QA Specialist, for a BioPharma client site in South Dublin
12 month initial contract, with potential extension.
Hybrid - This role requires the successful candidate to be on site once a quarter and on a adhoc basis as required.
**Candidate must be located in Ireland.**
In this role you will be serving patients through internal collaboration with the client’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill the client’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.
In this role you will be part of the Global Supply Quality team supporting oversight and maintenance of contract manufacturers.
Department Name: External Supply Quality, Contract Development & Manufacturing Quality
Responsibilities include but are not limited to:
* Act as disposition manager ensuring that batch disposition activities are completed in line with company standards
* Manage and drive Quality records to closure including deviation records, investigation reports
* Initiate Quality records for supplier related changes.
* Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
* Provide data to the networks to support Quality Management Processes)
* Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
* Take part in operational and quality improvement initiatives, programs, and projects.
* Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.
Qualifications & Experience:
* Master’s degree & 2 years of directly related experience OR
* Bachelor’s degree & 4 years of directly related experience OR
* Associate’s degree & 10 years of directly related experience OR
* High school diploma / GED & 12 years of directly related experience
Must-Have Skills:
* Working foundation in quality assurance roles.
* Minimum of 4 years working in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.
* Ability to have a positive impact on others; the ability to affect the behaviours of others by connecting with and inspiring them
* Previous experience in batch release activities
* Good working knowledge of SAP
* Good-to-Have Skills:
* Experience in investigations, project management and trending and analysis
* Relevant experience in Supplier Management, raw materials, packaging components, and/or device manufacturing.
* Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
* Proven experience in designing and/or improving processes at conceptual level
* Desire to partner with internal and external stakeholders across teams
* Understanding of industry requirements/expectations of a robust Quality Management System and documentation.
Soft Skills:
* Excellent analytical and troubleshooting skills.
* Strong verbal and written communication skills
* Ability to work effectively with global, virtual teams
* High degree of initiative and self-motivation.
* Ability to manage multiple priorities successfully.
* Team-oriented, with a focus on achieving team goals
* Strong presentation and public speaking skills.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up-to-date CV to chloe.slingsby@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance and Manufacturing
* Industries
Pharmaceutical Manufacturing and Manufacturing
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