Senior QA Advisor (12 months fixed term contract)

UK - Hoddesdon

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Job Specification

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!

 

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.

We are based in Hertfordshire, in the town of Hoddesdon. The Hoddesdon campus, consisting of several purpose built scientific and administrative buildings together with a purpose built conference STE area has more than 5,000m2 of premier R&D space and houses established Process Chemistry, Analytical Chemistry and Drug Discovery teams, and a newly formed Formulation Development department. The Hoddesdon site has state-of-the-art Good Manufacturing Practice (GMP) standard facilities for the development of Active Pharmaceutical Ingredients (API), formulation development and process chemistry.
 

Job Summary

At our Hoddesdon site, the QA team are responsible for providing GMP advice and support, and act as the final approvers of any GMP intermediate and API batches manufactured in our pilot plant facility. We are currently seeking a Senior QA Advisor to on a 12 months Fixed Term Contract to join our team and ensure the integrity of production processes and systems to qualify for and maintain GMP status in API manufacture.

 

Key Roles and Responsibilities:

  • To write, review and Approve SOPs and other controlled documents.
  • To conduct internal Audits, as delegated by the Senior Quality Assurance Director.
  • Perform periodic reviews of Quality Systems, including Deviations and Vendors.
  • To support the Vendor Management process, performing Vendor Qualifications, Vendor Audits and Vendor Reviews.
  • Draft Technical Agreements for Critical Vendors and Clients.
  • 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.
  • Develop GMP Training Materials as well as provide GMP Induction Training for new-starters and ensures annual GMP Training is provided to all employees.
  • Develop Training Materials for key Quality Systems, including Deviations and Change Control and provide training in Quality Systems for non-Quality personnel.
  • Administer the Training System, providing guidance to the Departmental Training Coordinators. Manage the Training Matrix and provide monthly metrics on Training Performance.
  • Support the Health and Safety Manager to ensure employees are suitably trained in the appropriate Risk Assessments.
  • Review Batch Records.
  • 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.

Qualification

  • A minimum of a BSc degree in chemistry or related science subject area

 

Knowledge & Skills

  • Experience in Quality Assurance within API/Pharmaceutical environment
  • Knowledge of current GMP guidelines and industry trends regarding data integrity
  • Knowledge of ICH Q7a
  • Strong stakeholder and relationship building skills
  • Ability to communicate effectively at all levels within a large organisation
  • Ability to influence

 

Why Should You Apply?

  • This is an opportunity for you as a QA Advisor with GMP experience to step up into a senior Quality Assurance role with a API/Pharmaceutical background to demonstrate your ability to make a real impact in a fast-growing and highly respected CRO striving to become the world leader in contract research services
  • Build and shape your career in an environment that sets and commits to the highest standards of scientific research
  • 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 2003, 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 15,000 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.

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