QA Advisor

We are looking for:
 
A QA Advisor to join us on a 12-month FTC, to ensure the integrity of production processes and systems, to qualify for and maintain GMP status in API and Drug Product manufacturing.

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:

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 uphold 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 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. Promote the culture that ‘Quality is everyone’s responsibility’.  To manage the issuance of SOPs and other controlled documents. To conduct internal Audits, as delegated by the Senior QA Director.  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.  Provide Quality representation and input at project and planning meetings. Release materials for the production of GMP product as requested.  Support Qualification / Validation activities where requested.

Requirements:
 

A minimum of a BSc degree in chemistry or related science subject area Knowledge of current GMP guidelines and industry trends regarding data integrity. Knowledge of Eudralex Volume 4 Part I and Part II. Good attention to detail. Logical problem solving skills. Competent administrative skills. Organizational and leadership skills. Good oral and written communication skills Strong interpersonal and relationship building skills. Able to communicate effectively at all levels within a large organisation. Influencing skills. Team working skills. Time Management skills. Industry 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 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.

---