Senior QA Officer
3 months ago
Summary of the Senior Quality Assurance Officer role
As the Senior Quality Assurance Officer, you will report directly to the Senior Operational Quality Manager and be based at our site in Cramlington, Northumberland. This is a site-based role working Monday-Friday dayshift.
Working as part of our onsite Quality team, the main purpose of your role will be to perform batch sentencing activities on a named set of products and all quality assurance activities (reviews/approvals/audits etc) relating to those products and specific plant/business areas. You will maintain operational quality systems covering specific areas of expertise, working in accordance with cGMP and regulatory standards.
Please note that we are not able to offer sponsorship for this role therefore applications outside of the UK will not be considered.
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
- Sentencing all controlled intermediates and finished goods in an agreed timeframe, in accordance with written procedures. These cover production and analytical review, deviation and change assessment.
- Responsible for all quality assurance approvals of Process Record Sheets (PRS's), changes (process, analytical and engineering procedures) which relate to specific products to ensure they are carried out in accordance with relevant product registrations and customer notification requirements.
- Performing quality assurance assessment of all 'Decision Paths', non-conformances, and deviations (including out of calibration).
- Reviewing all cGMP cleanouts and ensuring manufacture is not commenced prior to completion of a satisfactory cleanout.
- Approving all documents including master Process Record Sheets (PRS's), monographs and procedures.
- Using Master Control electronic quality management system for document/deviation approvals etc and SAP for batch management/release.
- Complying with all environmental, health and safety requirements.
- Embodying our company values; Be Transparent, Be Willing, Be Reliable and Be Caring.
Requirements for the role
- Experienced in quality compliance management.
- Ideally educated to a degree level or equivalent in a science discipline.
- Good problem solving, lateral thinking and written/verbal communication skills together with an ability to cooperate effectively within a multidisciplinary team.
- Knowledge of cGMP, MHRA and other regulatory requirements is essential.
- 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.
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