Validation Expert

Linthwaite, Huddersfield

About the Company:

Thornton & Ross are one of the UK's fastest-growing, leading producers of household pharmaceutical products & own some of the country's most loved brands such as Covonia®, Hedrin®, Cetraben® as well as the leading disinfectant Zoflora®.  Many people in the UK will have a product from Thornton & Ross somewhere at home. We are also a trusted & reliable provider of prescription products, including emollients, bone health products & generics to the NHS with 100 years’ heritage behind us

We are part of the STADA group. STADA Arzneimittel AG is a German Stock Corporation with headquarters in Bad Vilbel, Germany. STADA focuses on a two-pillar strategy consisting of generics, including specialty pharmaceuticals & non-prescription consumer health products.  Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries

Like all success stories, our company history started with a great idea. In 1895, a group of pharmacists had a common objective: The standardised production of medicinal products to ensure an effective and reasonable provision of healthcare. This was the beginning of STADA’s impressive development. We are now a leading manufacturer of high-quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, we continue to be a reliable and trustworthy partner. We help people regain and protect a dignified and able life. As STADA, we fundamentally care for people’s health as a trusted partner.

If you are ready for new challenges where you can make a difference to people’s health, you have come to the right place. We are looking for people with a great attitude and passion, who care about making a difference in the world.

About the Role:

The role exist to provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives.  On a day-to-day basis you will reposnibile for:

Validation / execution and review of protocol/report related to:

• process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution.
• review and assure that validation protocols and reports are technically correct.
• ensure protocols are executed as intended.

Technical improvement execution of:

• process improvements and scale-up.
• Ensuring technical batches generate sufficient process knowledge by thoroughly testing critical variables.
• primary packaging closure assessment during changes

Evaluate & Assurance of:

• packaging change, that the primary packaging closure - including materials
• stability of the product and do not deteriorate quality.

Master Batch Records

• Ensure that all critical and significant parameters are within written Instruction (i.e. Master Batch Record, Validation Plan), sufficient and appropriate for the product.

Deviation, Out Of Expectation, Out Of Specification, complaint handling:

• Lead product and process related investigations and deviations including complaints, Out Of Expectation,
• Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.

About You:

At STADA we talk about diversity as Uniqueness. Everyone is unique and we recognise our differences as a strength. Our values Entrepreneurship, Integrity, Agility and One STADA ensure our uniqueness thrives, enabling us to care for people’s health as a trusted partner. Empower your Uniqueness, bring your whole self to STADA. If you’re keen to add value and see results, thrive in a busy fast paced environment and have the can-do spirit that’s spearheading our success, bring those qualities.

What’s in it for You?

Rewarding our employees is important to us, which is why we offer a range of fantastic benefits, such as:

• Competitive base salary
• 25 days annual leave (plus bank holidays) and the opportunity to buy an additional 5 days leave.
• Generous Company Pension Scheme
• Life Assurance
• Annual bonus scheme.
• Employee Assistance Programme