Quality Assurance Manager (QMS)
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Job Type | Permanent |
Location | Westmeath |
Area | Roscommon, IrelandWestmeath, Ireland |
Sector | QualityManagementIT/Software |
Start Date | |
Advertiser | Darcy Ainscough-Denton |
Telephone | +353 1 574 6266 |
Job Ref | 0000 |
Job Views | 130 |
- Description
- Quality Assurance Manager – Team Horizon
We are seeking applications for an experienced Quality Assurance Manager for our client, who is a leading pharmaceutical company based in Westmeath. Reporting to the Quality Manager & QP, you will join the QA team and manage the QMS system, internal audits, validation and finalizing projects.
Why you should apply:
This is an exciting opportunity to join a fast-growing international company whose culture centres on making lives better. You would be working within a vibrant, entrepreneurial environment alongside passionate team members who share a vision to discover, develop & commercialise pioneering technologies and solutions.
This role attracts a competitive base salary and benefits package.
The client operate a hybrid policy, and this role can be performed with flexibility to work from home.
What you will be doing:
Maintain Quality Management System processes in line company procedures and cGMP for activities on-site (Batch Certification, Storage and Distribution)
Provide quality support and oversight for manufacturing activities conducted at third-party sites.
Review and approval of Change Control requests, Deviations, Complaints and CAPA’s to ensure compliance with all applicable requirements
Lead and manage investigations and root cause identification for on-site deviations
Management of internal and external audits
Lead and manage third party and vendor qualification activities
Participate in interdepartmental initiatives for continuous improvement of procedures, processes, and systems
Management of a growing team of quality professionals
Maintaining and improving quality metrics
Support regulatory inspections
Manage and execute on-site validation activities
Take on any further reasonable responsibilities as assigned to you by your manager
Provide quality support to product launch in new markets
What you need to apply:
Relevant Bachelor’s degree (or equivalent) in scientific discipline
Minimum of 5 years’ experience within a pharmaceutical manufacturing environment, Quality Assurance role at a similar level.
In-depth Knowledge of EU/US quality related pharmaceutical regulations
Strong working knowledge of EU Regulations (USP, ICH, EU GMPs, FDA etc.)
Experience in conducting vendor audits
Working knowledge of EU/US validation requirements
Must possess excellent organizational skills, planning, scheduling, the ability to follow and help drive complex processes, procedures, and systems
Willingness and capability to handle multiple responsibilities
Must have effective verbal, written and interpersonal skills
High proficiency in MS Office
Ability to work in collaborative and independent work situations and environments with minimal supervision
Must maintain a high level of professionalism