Overview
Phastar is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. With offices across the UK, US, Germany, Denmark, Kenya, Australia, India, China and Japan, Phastar is the second largest specialized biometrics provider globally, and the largest in the UK.
Our unique approach to data analysis, “The Phastar Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.
WHY PHASTAR
Accredited as an outstanding company to work for, Phastar is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.
Manage Quality Assurance Services within Phastar; Manage and maintain oversight of Company Policies, Standard Operating Procedures and Work Instructions, devise and implement the internal annual audit program, generate and manage the CAPA process, conduct internal audits and host external audits/regulatory inspections. Deliver appropriate GCP training to staff and ensure overall compliance with Clinical Trial Regulations and other applicable legislation.
Responsibilities
Employees may be required to perform some or all of the following:
· Generate and manage the internal audit program· Independently conduct and report audits in accordance with the internal audit program· Conduct Vendor Qualification Assessment Audits· Lead, manage and coordinate external audits and regulatory inspections· Maintaining tracking of audits conducted and report status· Developing and Managing CAPA system including periodic reporting to management teams on company-wide issues / trends· Manage the administration of procedural documents including the coordination, review and update; oversee the implementation of new procedures.· Review and QA approval of all procedural documents· Deliver appropriate GCP training to staff· Develop measures of quality (Key Performance Indices) and monitoring systems for these measures; develop an implementation plan, roll-out and train staff on their use.· Periodically report Quality metrics to PHASTAR Management· Ensure company-wide compliance to clinical trial legislation and ICH GCP and other applicable legislation· Provide advice and interpretation on new regulations and regulatory issues as they occur· As part of the quality assurance function, ensure all staff have complete and accurate training records; train staff on SOP compliance and maintenance of their training records· Maintain personal training record· Perform role in accordance with company policies and Standard Operating Procedures· Ensure an overall awareness of the company processes· Ensure high quality is fundamental to PHASTAR culture· Quantify results of Internal and External Audits for surveillance at project and corporate levels.· Maintain an awareness of regulations that apply to the company, and ensure PHASTAR processes match these regulations · Designated Data Protection Officer for PHASTAR – maintain awareness of applicable Data Protection legislation and updates
Qualifications
· Educated to Bachelor's degree level or equivalent· Experience and training in regulatory affairs relating to clinical research and auditing· Familiarity with clinical trial regulations and Good Clinical Practice (GCP)· Computer literacy in Microsoft Windows, Microsoft Office (Word, Excel, PowerPoint)· Knowledge of Quality Management Systems
APPLY NOW
With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We’re committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.
Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the US or Canada as this role can be carried out remotely.
Phastar is committed to the principles and practices of equal opportunities and to encouraging the establishment of a diverse workforce. It is our policy to employ individuals on the basis of their suitability for the work to be performed and their potential for development, regardless of age, sex, race, colour, nationality, ethnic or national origin, disability, marital status, pregnancy or maternity, sexual orientation, gender reassignment, religion, or belief. This includes creating a culture that fully reflects our commitment to equal opportunities for all.
Important notice to Employment businesses/Agencies
Phastar does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Phastar's Head of Talent Acquisition to obtain prior written authorization before referring any candidates to Phastar. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Phastar. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Phastar. Phastar shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
