2021-359 – Senior Professional Cleaning Validation – Dublin Full Time

Purpose:

A vacancy exists for a permanent Senior Professional – Cleaning Validation (P5) within the Global MSAT FGMIE Department; reporting to the Global MSAT FGMIE Manager. You will lead aspects of cleaning validation programmes 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.

Responsibilities:

• Plan, co-ordinate and execute cleaning validation studies at site FGMIE.
• Support site VMP activities in area of responsibility
• Generate, execute or review Plans / Protocols / Reports / SOPs / WIs / WS associated with cleaning validation activities.
• Maintain cleaning validation files
• Participate as Validation Representative on Project Teams in area of responsibility.
• Participate in Change Control Programme.
• Adhere to the company’s Group Validation Policies, Guidelines and the Site Validation Master Plan.
• Keep abreast of / adhere to regulatory requirements in relation to area of responsibility.
• Ensure Project related work is carried out in accordance with the requirements of the company’s Group Validation Policies, Guidelines, Site Validation Master Plan and GMP.
• Participate in the Self Inspection programme and External Audit.
• Generate APQR reports in area of responsibility.
• Mentor Validation professionals in area of responsibility.
• Contribute to establishing Global standards for Cleaning validation across the site.

Minimum Qualifications and Experience: 

• The ideal candidate must have third level qualification (NFQ Level 8 or higher) in Chemistry/Pharmacy/Biology/ Engineering or other appropriate discipline.
• Minimum of 3 years relevant experience within quality, production or engineering function in the Pharmaceutical industry.
• 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 complex issues, in a timely manner.
• Achieves results while meeting deadlines and drives projects to completion.
• Communicates and influences decisions in their own area of responsibilities directly.
• A motivated self-starter.
• Acts with integrity and builds trust.
• 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.

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