Quality Assurance Auditor

4 months ago

Rushden, United Kingdom Pharmaron Full time

The position we are seeking to fill is for an **Quality Assurance Auditor (GMP) **to monitor the status and reporting of projects and other programmes independently and objectively, ensuring that such projects are fully compliant with the appropriate regulations and requirements.

**Qualification**

**Knowledge & Skills**
- Experience of compliance
- Experience of auditing and reporting
- Relevant work experience within CRO / Pharmaceutical environment is desirable
- Strong stakeholder and relationship building skills
- Good time management skills and ability to work to tight deadlines
- IT skills with a good knowledge of MS Office

**Key Roles and Responsibilities**:

- To assure that regulatory projects are performed in compliance with the appropriate cGMP regulations.
- To assure compliance with the regulatory requirements for GMP for API and IMP (small scale).
- To review stability/method verification protocols.
- To audit method verification reports.
- To review stability data and to audit reports.
- Conduct timely and effective Project Inspections, as directed by Line Manager, for GMP studies according to authorized documents and Company Standard Operating Procedures.
- Inspect critical phases of on-going Batch Manufacturing Records (BMRs), as directed by Line Manager, to determine that authorized documents (technical agreements, BMRs, etc.) and SOPs are being followed.
- To promptly report findings following audits and inspections to the Scientific Staff and Management.
- To resolve (with mínimal supervision) with Scientific Staff as necessary, apparent inaccuracies and irregularities, arising out of observations made during inspection / audit.
- To support the continuous Quality improvement by identifying Quality Events (e.g., Deviations, OOS, change controls) and advise Scientific Staff and Management accordingly.

**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

**Why Should You Apply?**
- This is an opportunity for you as a professional to step up into your career in Quality Assurance and 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, solve challenges and put excellence at the heart of all that we do.

**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, near 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 Chemistry QA team are responsible for assuring compliance with cGMP with the Metabolism QA team being responsible for assuring compliance with the Principles of GLP and GCP with both QA sections 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.
- 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.
- 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 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._
- Seniority Level

Associate
- Industry

Pharmaceutical Manufacturing
- Employment Type

Full-time
- Job Functions

**Benefits**:

- Additional leave

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