Quality Assurance Manager GCP
- Experience Level
I am working on a New opportunity for a Quality Assurance Manager to join a young ambitious international biopharmaceutical company.
If you are driven, ambitious and looking for an exciting career move then contact me to discuss further..
You will be a part of the management team with overall responsibility for the Quality Management System.
Main Duties / Responsibilities:
- Maintain and develop the Quality Management System in accordance with relevant regulatory requirements and business need.
- 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.
- 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.
What you need to succeed:
- Ambition and ready for a new challenge in a fast-paced environment
- Third level qualification in a scientific discipline
- A minimum of 3 years GCP and GMP experience in the pharmaceutical or clinical industry
- QA auditing experience
- Knowledge of relevant regulatory requirements
- Excellent interpersonal, communication, and problem-solving skills.
- Flexible in reacting to changing priorities in a dynamic business environment.
- Ability to travel as required.
For confidential discussion and further details contact Tina at +353 1 2784701 or 087 6811990 or email your CV to firstname.lastname@example.org
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com