Qualified Person

Description:

Catalent, a global leader in contract development and manufacturing (CDMO), is seeking a Qualified Person to join the Clinical Supply Services team at its Bathgate facility. This role is responsible for ensuring the quality and compliance of clinical supplies, acting as the site’s QP, and providing expert oversight and certification of finished products for clinical studies.

Responsibilities:

• Certify finished products prior to release for clinical trials

• Review and approve GMP documentation, including deviations and batch records

• Liaise with internal and client quality teams to support batch release and continuous improvement

• Participate in product recall investigations and regulatory compliance activities

• Fulfil QP duties in accordance with Directives SI 2012/1916 and SI 2004/1031

• Drive quality improvements in a compliant and controlled manner

Requirements:

• Qualified Person under SI 2012/1916 and/or SI 2004/1031

• Experience with sterile and biological products; ATMP experience advantageous

• BSc or equivalent in a scientific discipline (e.g., Chemistry, Biology)

• Strong knowledge of GMP regulations and quality systems

• Excellent communication skills and attention to detail

• Ability to work cross-functionally and make decisive quality decisions

Benefits & Support:

• Competitive salary, bonus, and benefits package, including site performance bonus

• Pension scheme matching up to 7.5%, life assurance, and BUPA private medical insurance

• Generous holiday entitlement with option to trade leave

• Career development through high-quality training, mentoring, and global network opportunities

• Health and wellbeing support including employee assistance programmes, on-site facilities, and inclusive Employee Resource Groups

• Excellent location with free on-site parking