Quality

Document Specialist QMS

Document Specialist QMS Our client is a highly ambitious young Biopharmaceutical company, seeking a strong self-starter experienced in setting up and maintaining QMS documentation processes. Job Spec Perform system administration tasks and Document Controller Role in the electronic document management system (eQMS) which manages all QMS controlled documents such as SOPs, Policies, Work Instructions, forms, templates, etc. Liaise with document owners to manage QMS new and/or revised controlled documents through eQMS lifecycle including: formatting QMS documents to company defined formats managing review and approval process issuing QMS documents assigning training managing Period...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

124289

Head of QA Management, Biotech

Head of QA Management, Biotech Our client, a multinational biotech company, now seek an experienced Head of QA Management, who will lead QA Operations across multiple products through to commercial manufacture and have full responsibility for management of experienced QA team. This role will act as a designee to the company Site Quality Head as required. The successful candidate will have full responsibility oversight of all Quality Assurance biotech operational activities including; batch disposition and material status control activities, batch manufacturing records, leading investigations and audit preparation within sterile manufacturing facility. Responsibilities for Head o...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

124283

Principal Quality Auditor, Drug Products

Principal Quality Auditor Our client, a pharmaceuticals company based in Ireland, now has approval for the new role of Principal Quality Auditor for their broad product portfolio, including marketed drug products and some generic products. The remit of this role is across Europe and Middle East geographical regions. This role is approved at Principal level and will report to the Senior Quality Auditing Manager. As a Quality Assurance Subject Matter, the successful candidate will exercise their QA oversight and auditing expertise in across internal (the company's business units and internal manufacturing sites) and external network (supplier, vendors, CMOs, etc.) ensuring product...

Job Type:

Permanent

Location:

Leinster

Salary:

N/A

Job Ref:

124277

Senior Quality Assurance Specialist

Senior Quality Assurance Specialist -Perm- Hybrid The Senior QA Specialist role is an advanced position requiring significant expertise/specialisation in area with responsibility for day-to-day implementation of Quality Systems and Compliance functions appropriate for combination product(s) (devices). Reporting to the Manager, Quality Assurance, RESPONSIBILITIES: The role is responsible for Quality oversight of commercial manufacture in compliance with Good Manufacturing Practice (GMP) requirements Executing Quality Management System requirements in support of commercial and developmental programs Ensuring the realisation of industry best practices for GxP Serving as quality app...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

124273

Associate Director, Clinical Quality and Compliance (GCP)

Associate Director, Clinical Quality and Compliance (GCP) Our client, a cutting edge scientifically driven Biotech company with commercial product and strong development pipeline, now seeks an experienced Associate Director Clinical Quality and Compliance (GCP) to support all therapeutic areas and clinical development programs.   This successful candidate will act as Subject Matter Expert regarding Clinical Quality and Compliance (GCP), performing global risk assessment for investigator site and vendor audit planning. This hire will lead cross-functional teams, including global clinical study management teams advising on areas of GCP risk and mitigation of such, promoting a cult...

Job Type:

Permanent

Location:

Dublin

Salary:

N/A

Job Ref:

124272