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- Cheshire, North West England
- Permanent
- Competitive salary plus great benefits
- Standard
- Expires In a month
Summary of the QA Document Controller role
As the QA Document Controller, you will report directly to the QA Manager based at our site in Deeside, North Wales. This is a site-based role Monday-Friday with flexibility in start/finish times.
As the Document Controller you will be responsible for maintaining and updating the cGMP document system that supports the efficient control and management of documents 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.
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.
Your responsibilities
- Maintaining and updating a cGMP compliant document and data control system.
- Managing all aspects of paper and electronic document (Master Control EDMS/EQMS) control onsite and the archiving system.
- Working closely with all functions and departments to ensure efficient running of the system according to cGMP and other regulatory requirements.
- Managing the process of distributing and communication documents with both internal and external bodies.
- Managing and organising the availability of documents during customer and regulatory inspections.
- Working as an integral part of the Quality team.
- Managing continuous improvement of documentation.
- Ensuring document tracker and metric systems (e.g. SOPs, CAPA, Deviation, Change Control) are up to date and document owners are informed of requirements.
- Embodying our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.
Requirements for the role
- Master Control or similar EDMS (Electronic Document Management Systems) knowledge.
- Previous experience within a GMP environment or highly regulated industry.
- Experience in documentation control.
- Excellent organisation skills with the ability to work accurately paying high attention to detail.
- Must be able 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 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.