Job Introduction
We are looking for:
A QA Advisor to implement and maintain a compliant and effective electronic Quality Management System (eQMS) to support the integrity of production processes and systems for API and IMP Drug Product Manufacture.
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 write and review SOPs and other controlled documents.
- To manage the issuance of SOPs and other controlled documents.
- To conduct internal Audits, as delegated by the Senior Director, Quality Assurance.
- Perform periodic reviews of Quality Systems, including Deviations and Vendors, as required.
- To support the Vendor Management process, performing Vendor Qualifications, Vendor Audits and Vendor Reviews, as required.
- To assist with preparation and to provide support for audits by both clients and regulatory authorities (e.g. MHRA).
- Ensure Deviations, Change Controls and OOS are tracked.
- Investigate Deviations, Quality issues and trends and contribute to continuous improvement.
- Follow up on CAPAs to ensure timely completion of actions and ensure status visibility.
- Administer the Training System, providing guidance to the Departmental Training Coordinators. Manage the Training Matrix and provide monthly metrics on Training Performance.
- Manage the Archiving of GMP documentation.
- Promote and contribute to a best in class Quality culture based on collaboration.
- Provide Quality representation and input at project and planning meetings.
- Review Batch Records.
- Provide Customers with high Quality service and high Quality products.
- Create and encourage a transparent and trustworthy environment.
- Performs roles and duties in accordance with current Good Manufacturing Practice guidelines and principles, and Pharmaron Hoddesdon Policies, Standard Operating Procedures, and Supporting documents.
- At all times upholds the highest professional standards and acts in the interest of the patient / patient safety.
- Ensures both initial and continued personal training is carried out and adapted according to need. Ensure all employees that they are suitably trained in all processes before undertaking where appropriate.
- Encouraging continuous improvement through an effective Quality Management System (QMS) striving to improve processes and practices.
- Promote and contribute to a best in class Quality culture and reputation based on collaboration.
- Promote leadership collaboration and employee engagement with the same Quality goals ensuring GMP compliance.
- Promoting the culture that ‘Quality is everyone’s responsibility’
Requirements:
- A minimum of a BSc degree in chemistry or related science subject area
- Minimum 2 years’ experience in Quality Assurance within Pharmaceutical environment
- Experience of eQMS administration or management
- Knowledge of current GMP guidelines and industry trends regarding data integrity
- Knowledge of Eudralex Volume 4 Part I and Part II
- Organizational skills
- Leadership skills
- Able to communicate effectively at all levels within a large organization
- MS Project and office Experience
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 Senior QA 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.