Quality & Regulatory Officer

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Regulatory & Quality Officer. The role will report to Regulatory & Quality Manager.        

To support the regulatory activities and the maintenance of the company Quality Management System (QMS) in the Irish affiliate in addition to acting as a back up for the safety function. The overall purpose of the role is to ensure product quality, regulatory compliance and patient safety with a focus on business-critical issues that may have an impact on license to operate and inspection readiness. 

Main accountabilities                                                                                                     

Regulatory:

• Support all regulatory affairs activities for medicinal products and medical devices on the Irish market
• Ensure compliance with regulations, laws and industry policies that affect company products
• Support the lifecycle management of product licenses, ensure submissions and approvals are timely and in line with HQ strategies.
• Ensure high quality compliant labelling for all marketed products
• Work collaboratively with other affiliates regarding shared labelling and any other applicable shared regulatory activities
• Communicate planned changes to regulatory files and products to relevant stakeholders within the affiliate
• Review and update local regulatory SOPs
• Ensure timely updates of critical systems, e.g. Regulatory Information Management System (RIMS), to ensure compliant product is released to the market
• Work collaboratively with the relevant Country, Regional and HQ teams to establish, prepare and implement regulatory strategies within agreed timescales
• Interface, collaborate and negotiate with external stakeholders such as relevant government agencies (e.g. HPRA, HSE) and industry associations (IPHA) to ensure continued compliance and to gain knowledge of new requirements that require local implementation

Quality:

Quality Management System (QMS) – Advice, support and training to the affiliate with the following Quality processes:

Audits & Inspections - ensuring compliance by:

• Acting as Finding owner / Action Owner / Approver Role (Internal Quality/GDP Audits)
• Support local audits and inspections as required

Change Control - challenging and implementing change by:

• Acting as Change Responsible and QA Approver

Content Control - ensuring simplicity and compliance by:

• Acting as Content Responsible
• Acting as Editor and QA Approver for local documents

Contracts & Quality Agreements - driving a strong quality culture by:

• Supporting the review of Quality Agreements and participating in quality activities with external distributor

Deviation Handling - ensuring quality by:

• Acting as Local Deviation QA Approver, Responsible and Action Responsible

Sample Handling

• Local medicinal product Sample Coordinator or Approver 

External/Local Requirements - driving compliance by:

• Acting as Monitor and Implementer of relevant local Health Authority laws and requirements in affiliate

Archiving/Record Management 

• Local Records Manager and Local Quality Assurance (QA) within Records Management for the affiliate  

ISOTrain & training management - ensuring compliance by:

• Maintain ISOTrain content, update and monitor completion 
• Interface with BA ISOTrain Training Coordinator and Super User to ensure assignment of training in ISOTrain for Ireland employees
• Escalate ISOTrain issues to ISOTrain Site Super User Local guidelines and SOPs:
• Update and align to ensure compliance of local processes with corporate cross functional SOPs, corporate systems, quality and regulatory requirements. 

Crisis Response

• Review and maintain Emergency and Crisis Response Plan for Ireland  Potential/Actual recall - ensuring quality by:
• Supporting the local affiliate with recall process

Quality Management Review (QMR) and Quality Activity Plan (QAP) - ensuring simplicity and compliance by:

• Support the compilation of the annual QMR report and input to the continuous improvement of the local QMS including the QAP

Wholesaler Distribution Responsibilities and Good Distribution Practice  - implement and challenge by:

• Acting as reviewer/approver on internal quality activities related to internal GxP processes, such as storage/transport/temperature deviations
• Act as Deputy Responsible Person

Other

• Local Quality related projects
• Act as reviewer/approver for IT processes
• On-going monitoring & coordinating tasks to ensure Quality KPI are achieved and maintained

Safety and Complaints handling 

Act as back-up to Safety Officer to

1. Ensure compliance of safety reporting requirements in compliance with regulations and internal requirements 
2. Maintain surveillance of the safety mailbox
3. Support interpretation and processing of all product safety and complaint reports 
4. Document Safety and complaint related activities in the Customer Contact System Europe (CCSE) system
5. Case reporting to Global Safety (GS), Customer Complaints Centre (CCC)
6. Submission of expedited SUSAR reports, SUSAR line listings, DSURs and DMC statement to relevant stakeholders as per legal requirements
7. Archive of safety and complaint records
8. Ensure compliance tracking information to HQ 
9. Update the Global Safety ‘Data Collection Tool’ and ‘Global Rules Management System’ for Ireland
10. Reconciliation of safety information received during a MRP and PSP in accordance with SDEA  
11. Review identified Irish medical journals for reportable safety information
12. Act as ’legislation list monitor’ for Irish pharmacovigilance legislation
13. Ensure that QC of customer contacts in CCSE is performed

Requirements

• 3^rd level qualification, preferably in Life Sciences 
• At least 3 years relevant industry experience in a similar role. Previous regulatory and/or quality experience desirable.  Proven success in ethical pharmaceutical customer facing role
• Knowledge of regulatory approval processes and affiliate quality management activities
• Effective project management, time management, organisation and prioritisation skills

For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671