Senior Validation Professional - Global Engineering
A vacancy exists for a permanent Senior Validation Professional within the Global Engineering Department for my Pharma client based in Dublin; reporting to the Engineering Projects Manager.
You will lead aspects of validation programs for the company in order to meet appropriate GMP regulatory and validation requirements. You will also be a Subject Matter Expert in the area of responsibility.
Roles and Responsibilities include (but are not limited to):
· Plan and perform equipment and product qualifications.
· Co-ordinate/ perform utilities qualification studies.
· Co-ordinate/perform sterilisation/sanitisation validations studies.
· Co-ordinate/perform thermal mapping studies.
· Co-ordinate/perform transportation/distribution studies.
· Generate, execute or review Plans / Protocols / Reports / SOPs / WIs associated with commissioning, qualification and validation activities.
· Maintain qualification and validation files.
· Participate as Validation Representative on Project Teams.
· Participate in Change Control Programme.
· Adhere to Group Validation Policies, Guidelines and the Site Validation Master Plan.
· Keep abreast of / adhere to regulatory requirements in relation to validation areas of responsibility.
· Ensure Project related work is carried out in accordance with the requirements of LEO Group Validation Policies, Guidelines, Site Validation Master Plan and GMP.
· Participate in the Self Inspection programme and External Audits.
· Generate APQR reports in area of responsibility.
Key Skills and Experience:
The ideal candidate must have a third level qualification (NFQ Level 8 or higher) in Chemistry/Pharmacy/Biology/ Engineering or other appropriate disciplines.
Minimum of 3 years relevant experience within quality, production or engineering function in the Pharmaceutical industry.
Behaviours & competencies:
· A positive mindset of Safety First
· A confident team player who can work with a high degree of autonomy.
· Ability to engage and influence key internal stakeholders so that they can deliver on improved performance.
· Ability to make timely decisions at the right level with the right data and support them once made.
· Handle unfamiliar situations and solves problems to deliver results.
· Applies analytical skills and deepened knowledge to interpret data and applies independent judgement to tackle issues.
· Drives projects to completion.
· Communicates and influences decisions in their own area of responsibilities directly.
· A motivated self-starter
· Strong and proactive team player who thrives on working in a fast paced production environment.
· Has a continuous improvement mindset always looking at ways to improve with agility, simplicity and efficiency to the fore.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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