Vacancies

Associate Principal QA Advisor (12 Month Contract)

Please Note: The application deadline for this job has now passed.

Job Introduction

Associate Principal QA Advisor (12 Month Contract)

We are seeking an Associate Principal QA Advisor on a 12-month Fixed Term Contract to ensure the integrity of our production processes and systems to qualify for and maintain GMP status in API and Drug Product manufacture

Key roles and responsibilities:

To write, review and Approve SOPs and other controlled documents and conduct internal Audits, as delegated by the Senior QA Director.
To be the specific lead for assigned Quality Assurance systems (e.g. SOPs, Audits, Periodic Reviews, Data Integrity, Change Control, Deviations, OOS, QRM, Qualification) ensuring that they are maintained in an audit ready situation and that management is aware of any issues.
To support the Vendor Management process, performing Vendor Qualifications, Vendor Audits, Vendor Reviews, and approve technical agreements as required.
To represent QA on assigned project teams, and with assigned clients to be the main QA contact. Dealing with all associated client and project lead requirements, audits and documentation.
Draft Technical Agreements for Critical Vendors, as required and assist with preparation and to provide support for audits by regulatory authorities (e.g. MHRA).
Ensure Deviations, Change Controls and OOS are tracked and investigate Deviations, Quality issues and trends and contribute to continuous improvement.
Develop GMP Training Materials. Provide GMP Induction Training for new-starters and ensures annual GMP Training is provided to all employees.
Review and approve Batch Records and manage the Archiving of GMP documentation.
To undertake the release of manufactured API and Drug Product batches at Pharmaron Hoddesdon ensuring that all registered parameters and regulatory expectations are met.

Skills & Qualification

A minimum of a BSc degree in chemistry or related science subject area.
Experience in Quality Assurance within API / Drug Product Pharmaceutical environment.
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.
Strong interpersonal and relationship building skills.
Able to communicate effectively at all levels within a large organisation.

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 area has more than 5,000m2 of premier R&D space and houses established Process Chemistry, Analytical Chemistry and Drug Discovery team, and a newly formed Drug Product Development department. The Hoddesdon site has state-of-the-art Good Manufacturing Practice (GMP) facilities for the manufacture of Active Pharmaceutical Ingredients (API) and drug product to support clinical trials. We offer our employees a highly supportive team-work environment, enabling them to develop and liberate their true potential.

Why Should You Apply?

This is an opportunity for you as a successful Associate Principal QA Advisor 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 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