Senior Quality Assurance Advisor

4 weeks ago

Rushden, United Kingdom Pharmaron Full time

**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.

The role is based in Northamptonshire, in the town of Rushden. The Rushden site is a centre of excellence for Radiolabelled Sciences incorporating both Metabolism and Chemistry. At our Rushden site, the Metabolism QA team are responsible for assuring compliance with the Principles of GLP and GCP and for providing advice and support to ensure compliance is maintained.

We offer our employees a supportive teamwork environment, enabling them to develop and liberate their true potential.

The position we are seeking to fill is for a **Senior Quality Assurance Advisor **to monitor the status and reporting of studies and other procedures for compliance with the appropriate regulations and requirements.
- We offer state of the art equipment and facilities at our Rushden site.
- We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
- We offer the opportunity for growth and development.

**Key Roles and Responsibilities**:

- Assuring that regulatory studies are performed in compliance with the appropriate GLP/ GCP regulations.
- Conducting timely and effective GLP/ GCP Inspections.
- Conducting accurate and timely audits of the draft Reports.
- Performing Final Report/ Report Amendment audits and subsequent sign-off.
- Executing Process, System and Facility inspections to determine that Plans and SOPs are being followed.
- Reporting findings following audits and inspections to the Scientific Staff and Management.
- Investigating deviations from Plans or SOPs and to advise Scientific Staff and Management accordingly.
- Resolving with Scientific Staff as necessary, apparent inaccuracies and irregularities, arising out of observations made during inspection/ audit.
- Supporting continuous Quality improvement and advising Scientific Staff and Management accordingly.
- To write, review and authorise SOPs and Policies
- To assist with the training of junior members of QA staff and other members of staff within the company where appropriate
- To act as a mentor to more junior members of the QA team

**Qualification**:
**Knowledge & Skills**
- A minimum of 3 years GLP/ GCP auditing experience
- PC literate (with regards to standard office packages)
- Flexible and be able to work independently or as part of a team as required to meet the timelines
- Must be able to drive
- Key attributes: diplomatic, assertive, and mature with strong interpersonal skills
- Good communication skills (both written and verbal)
- Excellent attention to detail is essential

**Why Should You Apply?**
- This is an opportunity for you as a professional with experience to step up into a Senior Quality Assurance role with a GLP/ GCP auditing 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 2004, Pharmaron has invested in its people and facilities having established diverse drug R&D service capabilities, ranging from synthetic, medicinal, process 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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