Compliance & Validation Manager - Qualified Person

Compliance & Validation Manager - Qualified Person

City: Nottingham

We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Manufacturing

Our supply chain is the backbone of our business. It's how we get our trusted products to people all over the world, safely and efficiently. And it's our talented and passionate teams that make this happen. If you're looking for a career in supply chain, there's no better place to be than Reckitt. We offer a variety of exciting opportunities in all areas of the supply chain, from planning and procurement to manufacturing and logistics.

About the role

We are looking for a Qualified Person (QP) to join our Quality Leadership Team as Compliance and Validation Manager. In addition to performing batch certification and release activities, you'll work closely with the Technical and Engineering Teams to oversee validation activities in our solid dose manufacturing facility to ensure the successful introduction of new products and equipment and changes to processes.

Working in partnership with global Reckitt manufacturing sites as well as Third Parties who supply intermediate products to the Nottingham factory, you'll provide quality oversight of validation activities, assessment of changes and support the resolution of quality issues for batches supplied to the Nottingham site for further processing and batch certification.

You’ll work with the Site Compliance Manager to ensure the compliance of the QMS and MIA and drive timely implementation of changes to guidance and legislation. The role is proactive in identifying, communicating, and mitigating quality and compliance risks and driving continuous improvement.

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 experience we're looking for

• Eligible to undertake the duties of a Qualified Person as defined in SI 2012-1916 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.

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.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.