Role: QA Validation & Technical Operations Specialist (Sterile Drug Product)
Location: Dublin
Contract: 12-month contract

50% Remote

€530 daily rate

At Hays Specialist Recruitment we have a great opportunity for a QA Validation & Technical Operations Specialist to join our Biopharmaceutical client in Dublin on an initial 12-month contract.

This position will be in the Sterile Drug Product QA Technical Operations team.

This role will work in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification.

You will support GMP design reviews, and CQV / CSV / Automation through all phases of the project up to and including Equipment PQ.

The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products on-site.

The Sterile Drug Product project scope includes construction and commissioning of a new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities.

Key Responsibilities

• Provide support to start up activities (Design, Build, CSV / CQV), and GMP operational readiness

• Partnership with CSV & CQV teams in delivering the GMP scope of work associated with the startup of sterile drug product operations, including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation and documentation for manufacturing operations.

• Collaboration with functional areas for qualification to ensure knowledge transfer and robustness of control strategies.

• Drives and supports a culture of continuous improvement initiatives and safe working practices.

• Support Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.

Qualifications & Experience

Skills/ Experience required:

• Bachelor/Masters in Engineering, or Science related discipline with a minimum of 5 years’ experience in Sterile Drug Product Manufacturing

• Understanding and experience of the principles of Annex 1 and how they translate into a contamination control strategy for sterile manufacture.

• The candidate will have proven success working well in a team environment

• Detailed knowledge of Sterile Drug Product would be a distinct advantage.

• Required to work on his/her own initiative in addition to working as part of a team. Must be able to work across a team matrix to meet accelerated timelines.

• Excellent communication and presentation skills are essential.

• Excellent time management and organisational skills along with a proven ability to multi-task