Quality Assurance Auditor I/II London, England
Job description
KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.
We see human behind every number
Quality Assurance Auditor I/II
Location: Guildford, United Kingdom or home-based/Berlin; Berlin, Germany or home-based;
Warsaw, Poland or home-based; Tallinn, Estonia or home-based
Quality Assurance Auditor is required to perform quality and auditing activities in order to assess compliance with corporate requirements, industry standards and applicable regulations. Additionally, tasks may include, but are not limited to quality support to KCR clients/projects/teams, compilation and/or analysis of quality metrics, support of Quality Assurance e-system(s), participation in client and regulatory inspections, review of KCR corporate procedural documents and general assignments directed by Quality Assurance & Compliance Department Line Manager.
Your responsibilities:
- Plans, prepares, conducts, reports and leads follow-up activities for audits as supporting auditor
- Plans, prepares, conducts, reports and leads follow-up activities for audits as lead auditor
- Provides support during sponsor and regulatory inspections, as needed and/or required
- Participates in KCR procedural document review lifecycle
- Supports KCR project teams through provision of regulatory guidance and quality support
- Executes tasks as required per SOP, including but not limited, to CAPA processing and oversight,
corporate deviation processing and oversight, client complaints, corporate risks, ISO alignment - Develops, extracts, and/or analyzes Quality metrics
- Ad hoc trainings within KCR, as needed
Mentors junior staff members, as needed
Our requirements:
- University/college degree preferred
- 3 years experience in direct Quality Assurance function preferred with minimally 1 year in an auditing
capacity - Fluency in English, both spoken and written
- Working knowledge of local policies, procedures and guidelines, FDA and EMA and local regulations
which are applicable to the clinical research space/GCP and fundamental knowledge of CSV is
required; GMP and GLP knowledge is preferred however not required - Excellent written and oral communication skills and interpersonal skills in business environment
- Possess a technical knowledge that is applicable to clinical drug development
- Ability to manage work schedule independently, prioritizing tasks to benefit the organization
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.
What do we offer:
- Onboarding process and induction training to develop deep sector knowledge and complex skills
- Latest technology and the most advanced equipment and working tools
- An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement
- Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills
- Home-office working, remote
- An extra day off to celebrate your birthday
Our Privacy Policy
Your data will be processed in accordance with KCR Group Privacy Policy. For more details click here: https://www.kcrcro.com/privacy-policy/#privacy.
Providing your personal data is voluntary, however, if you do not provide us with the necessary information, we will not be legally allowed to get in touch with you and consider your application. By sending application documents containing your personal data to a wider extent than required by provisions of the applicable laws, you are granting consent for the data to be processed for the purposes of the ongoing recruitment.
You may also agree to enable other employers within KCR Group to communicate with you about potential job opportunities that match your area of expertise and interests.
If you would like your candidacy to also be considered for future recruitments, please select an additional consent or add the following statement to your application documents: “I agree to the processing of my personal data for any future recruitments conducted by KCR and/or KCR affiliates for a period of up to 3 years”. Such consent may be placed in your CV or electronic correspondence addressed to your potential employer.
You may withdraw any consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.
Your personal data will be shared with KCR and/or KCR affiliate that you are pursuing, and that company will be considered a separate data controller of your personal data. A full list of KCR affiliates is available at: https://www.kcrcro.com/privacy-policy/#kcr-entities.
You can contact KCR Group Data Protection Officer at [email protected] any time with any questions or concerns regarding how your personal data is processed.
KCR is an equal opportunity employer providing its staff with excellent opportunities to build dynamic, long-term careers.
