Change Control Lead
- Ireland, Midlands (Ireland)
- Contract
- Compliance / Quality Assurance
Do you want to be involved with exciting pharmaceutical projects?
When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a Change Control Lead.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Ownership and management of changes as associated with large strategic large projects. Changes may be related to processes e.g. equipment, automation and supply chain or other technical functions as required.
- Responsible for initiation, ownership, and management of changes through the change control systems.
- Preparation and progression of GMP and Non GMP changes in IPI, Vault QMS and Enablon systems.
- Collaboration with change initiators, subject matter experts, reviewers, approvers, and external manufacturing groups through the life cycle of relevant changes.
- Obtain approval for change from relevant review board.
- Impact assessment for relevant changes.
- Liaise with stakeholders for impact assessment and task identification.
- Aligning of system release strategy with stake holders/ operations.
- Identification and implementation of process optimisation opportunities where they arise. (e.g. Hierarchy or dependency optimisation, material control strategies).
- Maintaining accurate task scheduling per project requirements. Minimising the number of overdue tasks through schedule management.
- Engagement with the tier process to escalate changes or tasks that are off track.
- Conduct safety and quality walkdowns, as required.
- Ideally candidates should have a strong emphasis on change control documentation, a GMP/GDP background and a degree in a science and or engineering based discipline.
- Requires extensive experience.
- Experience of working in a project environment.
- Hands on attitude, specifically carrying out change controls to a very high standard.
- Excellent oral and written communication skills in English.
- High level of customer orientation/understanding.
#LI-TE1
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at QCS Staffing. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.
Global Pharmaceutical firm
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