QA Advisor - GLP - Quality Assurance Department - Rushden
QA Advisor - GLP - Quality Assurance Department
Based at Rushden
Pharmaron is a premier R&D service provider supporting the life science industry. Founded in 2003, 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, including applications of 14C microtracer AMS technology. With operations in China, US and UK staffed by over 4,500 employees, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
The Rushden site is the 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 and Plant Metabolism and Metabolite Identification) and Chemistry (which includes API and IMP manufacture).
Due to recent expansion Pharmaron are currently looking to recruit a QA Advisor at their Rushden facility within Q.A.
To monitor the status and reporting of studies (GLP/ GCP) as a function separate from and independent of the personnel engaged in the conduct of those studies.
To assure that regulatory studies are performed in compliance with the appropriate GxP, the Advisor will:
- Conduct reviews of Plans and Amendments for completeness and compliance with regulatory requirements.
- Inspect critical phases of on-going studies and procedures to determine that Plans and SOPs are being followed.
- Perform Process, System and Facility inspections to determine that Plans and SOPs are being followed.
- Perform audits of draft Reports confirming that methods, procedures and results accurately and completely reflect the raw data.
- To conduct timely and effective Study Inspections according to company Standard Operating Procedures and to promptly report findings to the Study Director/ Principal Investigator/ Analytical Project Manager and Management.
- To investigate deviations from Plans or SOPs (including the review of any corrective and preventative actions required) and to advise scientific staff and Management accordingly.
- To conduct accurate and timely audits of the draft Reports according to company Standard Operating Procedures and to promptly report findings to the Study Director/ Principal Investigator/ Analytical Project Manager/ System Manager and Management.
- To resolve, with study staff as necessary, apparent inaccuracies and irregularities, arising out of observations made during inspection/ audit.
- To maintain an alert and enquiring attitude to Study Conduct and Study Reports with the object of making recommendation for improvement or extension of company SOPs.
- Comply at all times with the Laboratory Safety Policy.
- Comply with the specific Good Practice requirements whenever appropriate to the work being undertaken.
- The ideal candidate will ideally have up to 2 years previous QA experience
- This is a challenging role that requires a scientific background, ideally to Degree level with appropriate laboratory experience.
- The successful candidate must be diplomatic, assertive and mature with strong interpersonal skills. A common sense approach, good communicative skills (both written and verbal) and excellent attention to detail are essential.
- The candidate must be very 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.
- It would be an advantage if you have previous Q.A experience within a GxP environment but this is not essential as training will be provided.
The position is full time and permanent. Hours of work are 37.5 per week Monday - Friday. Annual holiday entitlement is 23 days a year plus Bank Holidays. The company operates a contributory pension scheme, life assurance and a flexible benefits package.
To apply please send a CV and a covering letter by clicking on the 'Apply' button quoting: Q.A Advisor