As the QA Specialist you will report directly to the QA Manager, based at our site in Deeside, North Wales. This is a site-based role with flexible working hours.
The main purpose of your role will be to maintain the quality management systems, ensuring there is adequate QA support for production activities (including batch review), project support, overseeing material management and approval of materials/service providers, approval of validation documentation, audit support activities and other QA activities onsite.
Sterling’s facility in Deeside site can be found lying alongside the waterways of the River Dee, presenting a quintessential glimpse of life in North Wales, with numerous nature parks, shopping centres and rural villages, providing plenty of opportunities to get out and explore. It’s just a short journey from the cities of Chester, Liverpool and Manchester or you can choose to go a little further afield and from the mountains of Snowdonia to the all Wales coastal path, walking is a dream in North Wales.
Sterling will support with relocation for the right candidate.
Who Are We?
We are a fast-growing global pharmaceutical CDMO (Contract Development and Manufacturing Organisation), with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). We are a proven and trusted partner to some of the world’s most innovative biotechs and leading pharmaceutical companies and are widely recognised for our expertise in complex and hazardous chemistry.
We are a dynamic business, employing more than 1300 talented and passionate people in the UK, US and Europe who together support our customers in bringing new medicines to market, improving and saving the lives of patients. We support our customers through the full product lifecycle from pre-clinical development right up to full scale commercial manufacturing and today we are proud to have built a culture of excellence in science and unrivalled service.
- Reviewing documentation (batch documents, logbooks, protocols, SOPs, forms etc.).
- Ensuring compliance with quality systems (documentation, deviation CAPA, change control etc.)
- Contributing to supplier QA programmes and new supplier qualification.
- Supporting and leading quality investigations, writing investigation reports and initiating/following up on corrective and preventative actions.
- Using, supporting and maintaining training systems, training programmes and training documentation.
- Proactively administering the Quality Management systems, metrics/KPI management and trending for Quality.
- Working closely with all functions and departments to ensure efficient document review according to cGMP and other regulatory requirements are compliant.
- Supporting and leading in self-inspections, customer and regulatory audits.
- Leading on quality-based projects.
- Supporting and leading other activities like Data Integrity activities, Quality Risk Management, approving pre and post execution validation documents, batch release of clinical and commercial bulk drug substance / API against product specification files.
Requirements for the role
- Minimum HND in a Biological subject, degree level preferred.
- Must have a proven track record in QA within the pharmaceutical or related industry.
- Previous experience in a QA role, dealing with QC and/or manufacturing would be advantageous.
- Practical experience of GMP and GLP systems.
- Knowledge and practical experience of Quality systems, Data Integrity, Supplier Management and Quality Risk Management.
- Numerical and investigative skills with ability to support and coach other functions in managing quality issues.
- Ability to work accurately, with attention to detail in documentation reviews.
- Ability to prioritise and deal effectively with a varied workload.
- Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation.
- Must be confident to constructively challenge results and performance when required.
- Must align to our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.
Why Consider Us?
Our collaborative and empowering culture is unique to us and is what really sets us apart as a business and this is built upon our four core values: Be Transparent, Be Reliable, Be Willing and Be Caring. We also run a variety of programmes across our sites to promote health, wellbeing and work life balance, in addition to supporting causes and charities close to our employees’ hearts, encouraging volunteering within the communities we are part of and even arranging socials, through our global social committees, to encourage team building and reward our team’s hard work.
At Sterling we promote mutual trust and respect regardless of your nationality, background, feelings, beliefs, gender or age. Our workforce, much like life, is made up of many different people with many different backgrounds, needs and perspectives. This is something we celebrate at Sterling, as it makes Sterling a better place to work and encourages innovation and collaboration.
We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Engagement Hub, cycle to work scheme, death in service coverage, on-site health and wellbeing support including medical consultations and physiotherapy, 24/7 employee assistance programme, employee referral scheme, sports and social club as well as opportunity for training and further career development.