Quality Product Associat

Join a dynamic quality team where you'll collaborate with global stakeholders and manufacturing partners to drive product quality and support the successful delivery of innovative therapies.

Proclinical is seeking a Quality Product Associate to oversee the quality and compliance of pharmaceutical and biologic products. This role focuses on ensuring timely delivery of high-quality products while maintaining compliance with local, divisional, and global regulations. You will collaborate with internal teams and third-party manufacturers to support product transfers, manage quality records, and contribute to new product launches.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Act as the primary quality lead for assigned projects, ensuring on-time quality deliverables.
• Perform final quality batch record reviews for products manufactured by third-party manufacturers.
• Ensure alignment and fulfilment of Quality and Technical Agreements with legal contracts.
• Establish and maintain open communication with third-party manufacturers, affiliates, and internal teams to address quality concerns and identify potential projects.
• Communicate and negotiate with external quality organizations to minimize compliance risks while balancing operational costs.
• Manage quality records, including Change Controls, Exception Reports, CAPAs, and Complaints, in a timely manner.
• Support quality assurance activities for new product launches, including coordination with third-party manufacturers.
• Facilitate investigations into complaint trends and manage exception documents and corrective actions.

Key Skills and Requirements:

• Degree-qualified in Life Sciences, Engineering, a technical field, or possess equivalent relevant industry experience.
• Proven experience within Quality Assurance Operations, with a solid understanding of pharmaceutical and/or biologics manufacturing processes.
• Knowledge of a range of pharmaceutical dosage forms, including sterile biologics, ointments, tablets, capsules, modified-release products, and active pharmaceutical ingredients (APIs).
• Strong analytical and critical thinking skills, with the ability to prioritise and manage multiple complex projects simultaneously.
• Excellent communication and stakeholder management skills, with the ability to operate effectively as a leader, collaborator, or independent contributor.
• Highly organised, detail-oriented, and able to work with pace and urgency in a dynamic, fast-moving environment.