QA Specialist - Sterile Manufacturing - BioPharma - Waterford


Location: Ireland

Negotiable

Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19273

Consultant: Karen McHugh






Do you have 3+ years of experience in a manufacturing environment with sterile experience?

Would you like to work for a multinational Biopharmaceutical company based in Waterford?

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call + 353 1 7978720 to discuss. 


QA Specialist - Sterile Manufacturing - BioPharma - Waterford


Employer

JobContax is a preferred supplier to one of the world's leading Healthcare companies. 

With major capital investment happening in their Waterford plant, this is an exciting time to join the team. 


Job Description

Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP

Implement and support a batch release system in the QA function of Sterile Manufacturing.

Support the development of GMP training packages and delivery of training

Participate in the preparation and review of procedures and batch documentation

Review and approval of deviation, CAPA’s, quality events and tasks

Ensure the quality system at Sanofi is effectively implemented and maintained.

Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues

Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk

Work with relevant departments to ensure timely closure of quality actions / findings

Actively contribute to continuous improvement initiatives.

Conduct duties in a safe manner and report all safety issues or concerns

 

Requirements

Bachelor’s degree in a science related subject is essential

3+ years experience in a manufacturing environment, sterile experience is preferable

Effective technical knowledge of sterile manufacturing processes

Operational experience of quality systems in a dynamic manufacturing environment

Knowledge of requirements for cGMP, US and EU regulatory requirements

Full understanding of relevant quality and compliance regulations

Able to manage projects to plan/budget

Effective facilitator

Good communication skills at organisation, team and individual levels

Understands KPI’s for the team and site

Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs


Package

Salary Negotiable depending on experience

Excellent benefits package

Flexible working hours

Further education opportunities


Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail karen@jobcontax.com or phone +353-1-7978720

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