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Compliance and Validation Manager

2 months ago

Nottingham, Nottingham, United Kingdom Reckitt Benckiser LLC Full time
About the Role

We are seeking a highly skilled Compliance and Validation Manager to join our Quality Leadership Team at Reckitt Benckiser LLC. As a Qualified Person, you will play a critical role in ensuring the compliance of our solid dose manufacturing facility with regulatory requirements and industry standards.

As a key member of our Quality team, you will be responsible for overseeing validation activities, assessing changes, and providing quality oversight of validation activities. You will work closely with our Technical and Engineering Teams to ensure the successful introduction of new products and equipment, as well as changes to processes.

You will also provide quality oversight of validation activities, assessment of changes, and support the resolution of quality issues for batches supplied to our Nottingham site for further processing and batch certification.

Your Responsibilities
  • Member of the site Quality leadership team, influencing the site's quality strategy and priorities
  • QP certification and release of finished product batches produced at the Nottingham site
  • Ensuring regulatory and corporate GMP requirements are maintained for all factory activities
  • Responsible for the Quality input and sign off of validation activity relating to facilities, introduction of new equipment, changes to current equipment, NPD/EPD and product transfers.
  • Key Quality contact working with Third Party and Reckitt manufacturing sites who supply intermediate and finished products to the Nottingham factory; working with them to resolve quality issues and support changes that could impact products supplied to Nottingham site.
  • Working with the Site Compliance Manager to host regulatory inspections, maintain manufacturing authorisations and implement changes in legislation and regulatory guidance to ensure the ongoing compliance of the QMS.
  • To provide Quality Technical support to NPD/EPD and manufacturing investigations where required.
The Skills We're Looking For
  • Eligible to undertake the duties of a Qualified Person as defined in SI and Directive 2001/83/EC
  • Broad understanding of pharmaceutical manufacturing operations, business and quality management systems
  • Thorough knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical products
  • Experience in pharmaceutical manufacturing of solid dosage forms
  • Demonstrated experience in risk management, change management and validation
  • Experience of hosting Health Authority inspections
What We Offer

At Reckitt Benckiser LLC, we value our employees and offer a range of benefits to support their wellbeing and career development. These include parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We also offer a range of other benefits in line with the local market, as well as opportunities for career growth and professional development.