Job Introduction
Senior Quality Assurance Advisor
UK – HODDESDON
We are looking for:
A Senior QA Advisor to join our Drug Product Development team at our site in Hoddesdon. In this role you will be responsible for maintaining the day-to-day operation of the Quality Management System to support GMP manufacture of API and Drug Product.
A Senior QA Advisor to join our Drug Product Development team at our site in Hoddesdon. In this role you will be responsible for maintaining the day-to-day operation of the Quality Management System to support GMP manufacture of API and Drug Product.
At Pharmaron we offer:
- Vibrant and dynamic employment – we are a highly specialised, growth company operating in a critical sector of the economy – our future is strong and exciting!
- Opportunities to develop your skills and yourself – our rapid growth brings greater opportunities for you to learn and grow faster!
- A great team where we all support each other – enjoy your work – after all you spend about a third of your time here!
Key roles and responsibilities:
- To input/ propose/ modify departmental SOPs/ SPTs.
- To conduct internal Audits and to assist and support external audits by clients and regulatory authorities.
- Perform periodic reviews of Quality Systems including the generation of metrics.
- To support the Vendor Management process, performing Vendor Qualifications, Vendor Audits and Vendor Reviews
- Investigate Deviations, Quality issues and trends and contribute to continuous improvement.
- Provides QA support on change controls and OOS.
- Follow up on CAPAs to ensure timely completion of actions and ensure status visibility.
- Write Quality Technical agreements with appropriate guidance and support.
- Support Qualification / Validation activities.
- Release materials for the production of GMP product
- Review and approve Batch records.
- Provide Quality representation and input at project and planning meetings.
- Review and approve stability protocols and reports.
- Review trend reports for Purified Water, Environmental Monitoring.
- Perform Quality Risk Assessments.
Requirements:
Essential:
- Degree level qualification in Chemistry or related Scientific subject
- Demonstrable experience in a Quality Assurance role within API/ Drug Product Pharmaceutical environment with experience within Oral Solid Dose (OSD) highly desirable
- Thorough Knowledge of current GMP guidelines, including Eudralex Volume 4 Part I and Part II and ICH guidelines.
- Good communication skills with the ability to communicate effectively at all levels within a large organization.
- Strong interpersonal and relationship-building skills with the ability to influence and encourage a quality mindset
- Excellent planning and organization skills – ability to multi-task, manage time and accept changing priorities.
- Work within and ability to effectively contribute to multidisciplinary scientific teams and environment
- IT Skills with a good working knowledge of MS office
Our Company:
“We are a dynamic, fast-growing company, with an enviable reputation for leading edge science, offering contract research services to some of the world’s leading pharmaceutical companies, solving what were believed to be unsolvable scientific challenges”.
We believe in our ability to relentlessly push forward the boundaries of scientific excellence, delivering solutions for our clients, always operating ethically and with integrity. We take pride in our professionalism and commitment to always deliver our very best work.
Pharmaron acquired the Hoddesdon campus, consisting of several purpose built scientific and administrative buildings together with a purpose built conference area in February 2017. The research building has more than 5,000m2 of premier R&D space and houses an established Process Chemistry, Analytical Chemistry and Drug Discovery teams. In addition, a Formulation Development team was also recently established. The Hoddesdon site has state-of-the-art Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API), Formulation Development (FD) and Process Chemistry (PC).
- We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
- We offer state of the art working environment on site.
- We offer the opportunity for growth and development and will support funding for relevant training and development programmes.
Why Should You Apply?
- This is an opportunity for you as a an experienced Quality Assurance professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
- Build and shape your career in an environment that sets and commits to the highest standards.
- To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.
Pharmaron is a premier R&D service company supporting the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, and analytical chemistry, biology, DMPK, pharmacology, drug safety assessment, radiochemistry and isotopically labelled metabolism, chemical & pharmaceutical development to clinical development. With operations in China, US and UK staffed by over 19,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan, and China.