Compliance and Regulatory Affairs Manager

1 month ago

Nottingham, Nottingham, United Kingdom Reckitt Benckiser LLC Full time

Home to the world's best loved and trusted hygiene, health, and nutrition brands, we are committed to making access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

About the role

As a Qualified Person supporting batch certification and release activities on site, you will work closely with Project Engineers and the Technical team to oversee validation activities, ensuring new equipment and changes to process and products meet the required quality standards.

  • Regulatory and corporate compliance to GMP is maintained for all factory activities.
  • Quality input and sign-off, of validation activity relating to facilities, introduction of new equipment, changes to current equipment, NPD/EPD and product transfers.
  • Implementation of NPD/EPD in factory with clear understanding of potential risks and actions identified to address them.
  • 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.
  • Non-compliance and failure risks are identified and displayed to Supply Management on existing processes and operations. Any change control process is robust in identifying and minimising risk.
  • Supports hosting of regulatory audits of factory to maintain manufacturing authorisations and export agreements to other countries.
  • Communication and display of performance indicators identifying outstanding risks to supply management.
  • Quality Technical support to NPD/EPD and manufacturing investigations where required.
The experience we're looking for
  • Eligible to act as a Qualified Person in the UK.
  • Broad understanding of manufacturing operations business and quality management systems.
  • Thorough knowledge of the legal requirements, rules and guidance covering the manufacture of pharmaceutical products in Europe.
  • QA systems audit experience is desirable with well-developed risk assessment skills.
  • Experience in pharmaceutical Manufacturing of solid dosage forms.
  • Experience of Validation, training and auditing.
The skills for success

QP, Qualified Person, Pharmaceutical, Manufacturing Operations, Quality Management Systems.

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. You will be rewarded in line with Reckitt's pay for performance philosophy.

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