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Head of QA Operations

Hybrid Working – 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 Head of Quality Operations is primarily responsible for aspects related to Quality operational activities with a focus on supporting the Process Unit structure on site. They will lead the Quality Operations team, delegating tasks and projects as appropriate towards the organisation’s goals. They will work with colleagues at all levels, to understand needs and implement responses, both proactively and reactively. They will progress the development of the team towards a model of excellence.

 

Key Responsibilities

 

  • Lead and manage the QA team responsible for Quality Operations function on site, including aspects as a minimum: Time and attendance, Recruitment, Training and competency, Performance reviews (appraisals), Conduct issues
  • Comprehensive understanding of current Good Manufacturing Practices and relevant international standards (inc. ISO 9001 and ISO 13485).
  • Actively manage the GMP strategy on site.

 

  • Support for external audits, including: Customer, Certifying body, Notified body, Health authority
  • Oversight, support and activities within the deviation systems, associated investigations and CAPA.
  • Oversight and support of customer complaint investigations.
  • Review of product quality review reports including analysis / interpretation of process capability information.
  • In liaison with the Quality Leadership Team, to set and monitor the budget for the department.
  • To conduct internal and external quality audits in line with the company schedule as required.
  • Monitor and report on quality KPIs and key quality data, contributing to the completion of routine MBR and Quality MBR reports.
  • Liaise as required with colleagues across the global STADA network.
  • Provide Quality input and support to relevant operational and commercial meetings
  • Safety and responsibility towards the environment is an integral part of all activities at Thornton and Ross. This will be a key consideration in the development of the factory, equipment purchases, improvement work and training.
  • Ensure activities and changes to equipment and working practices are made in line with applicable regulations and guidelines for products including licenced medicines, medical devices, cosmetics, food, and biocides.
  • Ensure all improvement opportunities are in line with ISO standards or other applicable standards. Ensure all manufacturing operations are defined and documented to ensure optimum performance.
  • Work to an agreed program of priorities. Provide regular feedback and progress reports. Proactively manage resources to ensure deadlines are met.
  • All individual employees are required to conduct themselves in such a manner that the equal opportunities policy is effective. Every employee should treat other members of staff with dignity and respect.
  • Lead the QA team in line with the company values at all times.

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, with the following:

 

  • Degree in a related science subject
  • Eligible to work as a Qualified Person under the provisions documented in EU Directive 2001/83/EC (and Human Medicines Regulations 2012)      
  • Extensive experience working directly with Quality Management Systems and in a production operations environment    
  • Able to communicate effectively with people at all levels in both giving and receiving of information. This includes verbal and written/electronic communications.                
  • Works effectively and maintains relationships with colleagues across all required functions on site.                           
  • Will have the ability and propensity to identify and resolve issues where required.           
  • Self-organised and able to manage their own workload with minimal supervision.                             
  • Knowledgeable in the letter and application of regulations and guidelines applicable to the products handled

 

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 / Wellbeing App
  • Car Allowance
  • Private Health cover
  • Hybrid working options

 

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This role is subject to background and reference checking. The findings of these checks may not exclude candidates from appointment but will be considered as part of the recruitment process.

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