Validation Lead

Who we are

Uniphar Group is a rapidly expanding diversified healthcare services business with a global footprint and a proud heritage in Ireland.  Since Uniphar became a publicly listed company in 2019, the Group has grown organically and through a series of strategic acquisitions, which continue to strengthen Uniphar’s international reach. 

Uniphar provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our expert teams. Uniphar is organised into three key divisions: Supply Chain & Retail, Commercial & Clinical (Med Tech / Pharma) and Product Access.

With a workforce of close to 3,500 spread across Ireland, United Kingdom, the Netherlands, the Nordics, Germany and the USA, Uniphar is a trusted global partner to Pharma and MedTech manufacturers, working to improve patient access to medicines and treatments around the world.

Culture at Uniphar

We pride ourselves in being truly entrepreneurial, innovative, collaborative, with a strong problem-solving ethos.  We have built working relationships which span decades with many of the world’s largest Pharma and MedTech companies. We believe that this is because we know how to build a relationship of trust with our partners - we put our customers and their patients at the heart of what we do and treat them with integrity and respect. Everything Uniphar does is enabled by our people. As we continue to grow domestically and internationally, we become more diverse.  This rich diversity fuels our business and enriches our culture.

This is a Maternity Cover Fixed Term Contract

Objective

The Validation Lead is responsible for the validation and coordination of validation activities across the Uniphar Group. The function will act to develop, implement and maintain a validation master plan and execute all activities as it relates to this plan. This role also include the execution and planning of validation activities for new equipment, as per the business need.

MAIN DUTIES & RESPONSIBILITIES

• Lead all interactions with regulatory agencies / auditors as they relate to validation.
• Develop validation documentation suite templates for the IQ/ OQ/ PQs along with validation protocols and reports.
• Design validation studies.
• Develop a validation master plan taking account of core competencies such as risk assessment and change management.
• Embed and alignment of Uniphar Group Validation Policy across Group entities.
• Critical analysis of validation data and processes.
• To work closely with all departments to ensure the operation of a validated environment according to GxP regulatory requirements.
• Develop and mentor validation teams and other departments across the Group to enable the growth of core validation methodologies.
• Work with the business to investigation deviations as they relate to validation, temperature, or equipment malfunction.
• Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.
• Coordinate the implementation or scheduling of validation testing with across the Uniphar Group.
• Conduct audits of validation across Group entities to ensure compliance with internal or regulatory requirements.
• Direct validation standards to achieve harmonization across the group.
• Communicate with regulatory agencies regarding inspection deficiencies and or validation plans / projects.
• Develop a strategic Uniphar Group approach to validation to ensure compliance with GxP regulation based on core validation methodologies.
• Guide and advise on Group projects as the subject matter expert on validation.
• Supporting the business in investigating any non-conformances which may impact validation.

QUALIFICATION, EXPERIENCE & SKILLS REQUIRED

• Third level degree in a science/engineering subject as a minimum.
• 3 years validation experience is advantageous.
• Good understanding and application of GMP and regulatory requirements.
• Experience of wide range of validations including equipment, cleaning and facilities validation plans.
• Excellent communication / interpersonal skills
• Attention to detail.
• People management skills are advantageous.

COMPETENCIES                                       

• Excellent interpersonal, verbal and written communication skills.
• Demonstrated ability to lead, direct and influence people
• Experience in the pharmaceutical wholesaling/distribution arena.
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