Quality Assurance Advisor- Gmp

1 month ago

Rushden, United Kingdom Pharmaron UK Hoddesdon Full time

**We are looking for**:
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.

**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

***

**Requirements**:

- 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.

**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. Based in Northamptonshire, our Rushden site is a centre of excellence for Radiolabelled Sciences incorporating both Metabolism (which includes Clinical Metabolism, Pre-clinical ADME, In vitro and DDI services, Large Molecule Metabolism, Environmental Fate, Plant Metabolism and Metabolite Identification) in addition to Chemistry (which includes API and IMP manufacture). We offer our employees a supportive teamwork environment, enabling them to develop and liberate their true potential.
- We offer a competitive salary and a progressive and comprehensive suite of employee benefits.
- We offer state of the art working environment in our specialist Rushen 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 Quality Auditor 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 of Chemistry.
- 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._

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