Process Lead

4 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

Overview

ProcessLead - Ireland, Dublin - 6 Month Contract (possible extension)

How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is the assignment for you Our client is currently seeking a ProcessLead to join their team. Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, with their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved

Responsibilities

- Set the technical direction and have overall accountability for the entire scope of work from initial concept through to successful operation
- Act as Technical Decision maker for their area of scope
- Review, accept and approve key technical documentation e.g. URSs, PIDs, FAT and SAT protocols
- Work closely with the site receiving team. This is pivotal for success in preparing for the hand over from the technology viewpoint, ensuring the stabilisation of the introduction and capabilities are appropriate within the team to achieve a smooth transition and beneficial operation.
- Ensure User Requirement Specification (URSs) are produced and are complete (GMP, GEP, and Safety, Health & Environment requirements), technically accurate and appropriate for calibration and qualification execution.
- Utilising LEAN and Change Management tools, provide strategic leadership to process improvement programmes sponsored by GERE or other senior stakeholders.
- Ensure business continuity in the respective areas is maintained and areas of concern are flagged.
- Support the planning and implementation of commissioning and qualification activities.
- Lead process risk assessments in order to establish and deliver safe process operations and have compliance when manufacturing products to their quality standards.
- Provide a leading input into process risk assessments (HAZOP, FMEA) in order to establish and deliver safe process operations and meet drug substance quality requirements.
- Be accountable for the technical input into the Design Review process and ensure that the project business objectives can be achieved.
- Provide technical support to facility, equipment, system in the commissioning and qualification process.
- Review and approve DQs, FATs and SATs for GMP‑critical systems as required.
- Attend relevant pre‑FATs/SATs to assure completeness, correctness and URS alignment can be delivered.

Desirable Experience

- Experience with API (Small molecule) & Process design
- Strong stakeholder management.
- Assess equipment needs and support the generation of equipment URSs and specifications for design or purchase
- Experience with GMP URSs, which will be agreed with project stakeholders in basic design
- Ensure requirements are understood and included in the scope of works of designer
- Consult in the C&Q plan

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