Compliance & Validation Manager

Descrizione del lavoro:

We are (COMPANY NAME)

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.

About the role

As a Qualified Person Supporting batch certification and release activities on site, you'll 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. As a key Quality contact working with Third Party and (COMPANY NAME) manufacturing sites who supply intermediate and finished products to Nottingham factory, you'll support the resolution of quality issues and changes that could impact products supplied to the Nottingham site. The role is proactive in identifying, communicating, and mitigating quality and compliance risks and driving continuous improvement.

Your responsibilities

* Batch release and certification of finished product produced at the Nottingham site.
* Regulatory and corporate compliance to GMP is maintained for all factory activities
* To be 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.
* NPD/EPD are implemented in factory with clear understanding of potential risks and actions identified to address them
* Key Quality contact working with Third Party and (COMPANY NAME) 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.
* Ensure that 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
* To provide 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
* Expected to have a proven track record in a manufacturing environment.
* QA systems audit experience is desirable with well-developed risk assessment skills
* Broad understanding of manufacturing operations business and quality management systems
* 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 (COMPANY NAME)'s potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with (COMPANY NAME)'s pay for performance philosophy.

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