We are currently looking for a Qualified Person to join a leading Pharmaceutical company based in the Waterford area.
As the Qualified Person you will be responsible for ensuring the licensed products are certified and released in accordance with EU directives.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Qualified Person will be varied however the key duties and responsibilities are as follows:
1.
Manage batch processes to ensure timely release in line with regulations and compliance.
2.
Participate in cross functional stakeholder management across all quality teams and representatives.
3.
Provide audit support for internal and supplier audits.
4.
Maintain and roll out up to date pharmaceutical legislations.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Qualified Person we are looking to identify the following on your profile and past history:
1.
Relevant degree at a MSc or equivalent qualification.
2.
Proven industry experience in cGMP and biologics manufacturing experience.
3.
A working knowledge and practical experience with site manufacturing regulations and legislations.
Key Words: QP | Qualified Person | MIA | EU Directive | Annex 16