BioTalent are representing a leading global biologics business in their search for a Qualified Person to join their expanding team on their state-of-the art manufacturing site. This is a critical hire to support the growth within the business and is offering the relevant individual the opportunity to help with the development of the department whilst being involved in exciting projects.

 

The QP will be responsible for directing quality and ensuring the consistent product output from their site. Holding full autonomous responsibility, you will be heavily involved in a hands-on all-encompassing role that allows access to the full spectrum of QA. You will have a detailed involvement in the quality processes surrounding a time-sensitive batch release and implementing managing the QMS.

 

This role will offer you:

• The opportunity to make a difference, by working for a company committed to producing life saving products.
• The opportunity to join a professional and well-established organisation whilst having a critical role in important exciting projects.
• Work at the forefront of science in a company renowned for its good company culture and state-of-the art manufacturing facilities.

 

You will bring the following:

• Proven people management skills.
• Ability to work effectively within a team as well as independently, exercising a high degree of autonomy.
• Experience releasing sterile products.

• Ensuring that all processes and procedures that are required for QP certification / batch release of drug substance are fit for purpose.
• Acting as a point of contact for queries relating to QP certification and batch release.
• Working with all necessary departments to ensure the cGMP Quality System is effective, with data integrity, and in full compliance with current guidelines and company filings.
• Identifying critical quality control apparatus and establishing the maintenance and calibration needs.
• Supervising and participating in the continuous improvement of the quality system.