Senior Quality Control Analyst
Location: Remote - Romania
Department: Compliance & Quality
At Suvoda, we’re not only passionate about the work that we do and the impact that it has on human lives, but we’re passionate about the people who make it happen! Every day, it is our priority to bring in talented and motivated individuals and create a workplace that drives, engages and retains them.
Our ideal candidate has prior experience with Python, and enjoys a dynamic, team-oriented work environment. If you are passionate about technology, enjoy collaboration, and have an analytical mindset, please explore the details below.
What Makes Suvoda a Great Place to Work?
Here are just a few highlights:
- The flexibility: Suvoda creates the perfect environment for people to integrate their work and life, by offering flexible working hours
- The growth and innovation: As part of a growing team, you’ll have lots of opportunities for career development and be exposed to the latest technologies due to our focus on innovation
- The office: Our newly renovated, modern office space is located in the city center and is equipped with comfortable work spaces, collaborative gathering areas and modern technology that easily connects you to all of our global offices
- The benefits: You’ll have access to a robust benefits package, meal tickets, a top subscription from Romania’s top healthcare provider, a fitness stipend, and competitive salaries with bonus plans
- The industry: By working in clinical trials, you’’ll be part of a challenging and rewarding industry that will allow you to develop your skills quickly while doing your part to change the world!
What Should You Expect?
Responsibilities:
- Ensure activities and deliverables are performed during the software development process as required by Suvoda procedures with little to no supervision and/or support from members of the Quality Control team
- Identify issues during the development of a Suvoda product (or delivery of a Suvoda service) before it is released and ensure that they are reported as per effective procedures
- Release Suvoda products and systems through the various phases of development
- Review and approve SDLC and validation deliverables
- Work with delivery teams, system owners or other stakeholders from the Compliance and Quality team to perform corrections and corrective actions, when necessary
- Perform in process verifications in accordance with Suvoda procedures
- Participate in the planning and execution of internal IT validation projects, including external party software validation and migration projects
- Support the onboarding and qualification of 3rd Party Vendors, as necessary, in accordance with internal procedures
- Identify and participate in process improvements projects, if and when required
- Act as a Subject Matter Expert (SME) in areas where expertise has been established, if and when required
- Author /review QMS documents,if and when required, with supervision and/or support from members of the Quality Control team
- Review deviations from Suvoda’s procedures with supervision and/or support from members of the Quality Control team
Manage and monitor quality assurance activities, including but not limited to:
- The review, approval, and processing of QMS documents
- Investigation of audit findings and execution of associated action plans
- Prepare, conduct, and manage follow-up for all audit types (i.e., customer, internal, and vendor)
- Provide back-end support for regulatory inspections of Suvoda and its customers
- Management of training requirements and records
- Respond to quality related questions from external parties including Suvoda’s customers
- Support the development and management of compliance & quality-owned processes and tools
- Support the development of and delivery of C&Q related training when necessary
- Works collaboratively intra-departmentally with others on quality functions and initiatives
Requirements:
- Bachelor’s degree
- Knowledge of GxP regulations, such as 21 CFR Part 312, Part 11, Annex 11 and ICH E6, preferred
- High-achieving personality
- Desire to learn and grow
- Strong work ethic
- Sense of ownership
- Proactive attitude
- Time management and organization skills
- Attention to detail
- Risk-based judgment
- Good communicationand technical writing capabilities
We are aware that an individual(s) are fraudulently representing themselves as Suvoda recruiters and/or hiring managers. Suvoda will never request personal information such as your bank account number, credit card number, drivers license or social security number — or request payment from you — during the job application or interview process. Any emails from the Suvoda recruiting team will come from a @suvoda.com email address. You can learn more about these types of fraud by referring to this FTC consumer alert.
As set forth in Suvoda’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.
If you are based in California, we encourage you to read this important information for California residents linked here.
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