REMOTE Quality Risk Management (QRM) Business Specialist
Company: ProPharma Group
Location: New York
Posted on: August 7, 2022
*Please note when applying this is a six-month remote
Company DescriptionProPharma Group is an industry leading, single
source provider for regulatory compliance, pharmacovigilance, and
medical information services across the full development lifecycle
for pharmaceutical, biotechnology, and medical device companies.
Operating around the world with offices in Australia, Canada,
Germany, Japan, the Netherlands, Sweden, United Kingdom, and the
United States, ProPharma Group's fully integrated service offerings
will provide clients with a comprehensive suite of global support
services that are required to be competitive in today's dynamic
markets. We build successful long-term relationships with clients
by providing leading industry knowledge, experience, and proven
Job DescriptionWe are seeking a talented Business Data Analyst to
join our Quality Risk Management (QRM) team. This role will be
focused in ensuring that the Quality Risk Management (QRM)
processes are followed across all Functions and Business Units
within the client.One of the key objectives of this role will be
focused on gathering QRM files, documenting, analyzing, and
determining any gaps with the current QRM processes as part of a
CAPA, and liaising/collaborating with stakeholders, subject matter
experts, and other team members to align them with the current
processes. Also assist in presenting the progress and results of
the analysis and deliver QRM training to stakeholders as
Job Duties & Responsibilities
- Compile data and develop analysis to support Quality Risk
Management file remediation/gap assessments.
- Engage with stakeholders and identify gaps in the Quality Risk
Management files in alignment with the current QRM processes.
- Assist in the solution implementation for a CAPA.
- Assist in conducting & establishing trending analysis of the
- Experience investigating and solving complex technical
problems, root cause analysis, and data discrepancies.
- Ability to work collaboratively, raise issues in a productive
way, and reach consensus in cross-functional settings.
- Operates independently and/or part of a larger project team to
fulfill tasks with little direction, documents results.
- Assist in presenting results of the gap assessments or training
- Record Meeting Minutes and Decisions when needed.
- Perform other related duties and special projects as required
- 2 to 4 years of experience in biopharmaceutical/pharmaceutical
or related industry
- Experience gathering, owning, and tracking changes to
- Experience in implementing CAPA solution as owner or part of
- Comfortable working independently as an individual contributor
and/or part of a larger project team
- Ability to work in a Global Team structure
- Familiarity with QMS technologies including Veeva and other
- Expert use of Microsoft Excel and comfortable with large amount
- Strong interpersonal communication skills
- Passion for continuous improvement and demonstrated problem
- High attentiveness to detail
- Broad understanding of Quality Risk Management (ICH Q9)
- Direct experience as CAPA owner
- Knowledge of cGMPs, GXPs and Quality Systems
- Expert use of Smartsheet Project Management Tools or ability to
- Experience in delivering training to a broad audience
- PMP or Six Sigma Certificate a plusEducationBachelor's degree
in chemistry, life sciences, engineering, business, or related
Additional InformationWe celebrate our differences and strive to
create a workplace where each person can be their authentic self.
We are committed to diversity, equity, and inclusion. Employees are
encouraged to unleash their innovative, collaborative, and
entrepreneurial spirits. With a holistic approach as an Equal
Opportunity Employer, we provide a safe space where all employees
feel empowered to succeed.This position may include the requirement
for occasional travel to client offices.All candidates must be
legally eligible to work in the United States.***ProPharma Group
does not accept unsolicited resumes from recruiters/third parties.
Please, no phone calls or emails to anyone regarding this
Keywords: ProPharma Group, New York , REMOTE Quality Risk Management (QRM) Business Specialist, Executive , New York, New York
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