Quality Assurance Manager – GCP
On behalf of our client, an international biopharmaceutical drug discovery and development company, we are currently recruiting for a Quality Assurance Manager GCP
Main Duties / Responsibilities:
- Maintain and develop the Quality Management System (QMS) in accordance with relevant regulatory requirements and business needs
- Implement an effective Quality Assurance process, including internal and external audit programs, and ensure timely completion of audits
- Lead the quality oversight process on outsourced activities, which includes; o Developing and maintaining Technical Agreements with vendors in line with relevant regulatory and business requirements
o Performance of onsite audits as required – vendors / clinical sites
o Analysis and reporting of Key Performance Indicators (KPIs)
- Oversee the effective documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions.
- Provide quality leadership and support to operational teams, including the review of batch records, technical reports and clinical trial protocols
- Manage the Documentation Control process, ensuring that policies and procedures are up to date, and available to all relevant parties
- Ensure that all activities are conducted in compliance with the requirements of Good Manufacturing Practice and Good Clinical Practice.
- Contribute to Company Training procedures as required
- Carry out various other additional tasks that may be required from time to time in accordance with the overall goals of the company
1) Scientific degree
2) At least 3 years GCP and GMP experience in the pharmaceutical industry
3) QA auditing experience
4) Knowledge of relevant regulatory requirements
5) Excellent interpersonal, communication, and problem solving skills
6) Strong computer skills
7) Flexible in reacting to changing priorities in a dynamic business environment.
8) Ability to travel as required
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. www.thornshaw.com Tel: +353 1 2784671