Job Introduction
Advisor, CSV Quality
UK - RUSHDEN
We are looking for:
We have a new opportunity an Advisor, CSV quality to join our small CSV Quality team based in Rushden. In this role you will be the Quality Assurance contact for Computerised System Validation enquiries and advise staff of the specific regulatory requirements. You will also support Data Integrity enquiries and be responsible for conducting audits for CSV and data integrity.
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!
Key roles and responsibilities:
- Conduct timely and effective audits for Computer System Validation (CSV) and Data Integrity (DI) according to company Standard Operating Procedures and to promptly report findings to the Responsible Person and Management.
- Conduct reviews of CSV Acceptance Test Plans and Amendments for completeness and compliance with regulatory requirements and to approve the final documentation.
- Investigate deviations from CSV Acceptance Test Plans or SOPs.
- Audit CSV Test Reports confirming that methods, procedures and results accurately and completely reflect the raw data.
- Conduct reviews of spreadsheets to enable a validated status.
Requirements:
- Degree in a STEM subject or relevant technical subject
- Quality Assurance experience within a GLP or GMP environment and experience of auditing and reporting is advantageous
- Interest in CSV with knowledge or experience highly desirable.
- Demonstrable ability to follow written procedures and to evaluate systems and records
- Ability to work to written systems and a methodical approach to performing duties
- Excellent attention to detail and a methodical approach
- Effective organizational and time management skills
- Appreciative of the need to comply with regulatory requirements
- Willingness to share information and help others
- Excellent communication and interpersonal skills with the ability to provide support to other teams
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 Quality or CSV 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.