Quality Compliance Specialist
Company: PQE Group
Posted on: June 25, 2022
*NOT OPEN TO C2C CONTRACTS*We are a service provider company,
leader in the Pharmaceutical and Medical Device sectors since 1998,
with more than 1200 employees, 45+ nationalities and 27
subsidiaries all over the world (Europe, Asia and the Americas).
Joining PQE means being a part of a multicultural and challenging
company, with many local and international projects, and colleagues
from all over the world.Due to constant growth, PQE is looking for
a new Quality Compliance Specialist. This will initially be a full
time six month contract-to-hire based assignment that will be
worked onsite in Indianapolis, IN.Responsibilities
- Execute management system compliance.
- Contribute to implement and maintain the relevant management
system, ensuring the compliance with the applicable regulations,
directives, standards and regulatory requirements.
- Execute continuous analysis in order to monitor national and
international standards, regulatory requirements and changes, while
working with the other functions involved client leadership.
- Assess the efficiency, proposing to the client effective
improvements and keep the management system updated accordingly to
relevant changes, while working alongside the other functions
involved such as internal auditing team.
- Participate in the procedure standardization, alongside the
different international plants and functions for fostering best
quality practice and promoting one quality approach.
- Audit and review management.
- Provide support to the client in the preparation of audit and
inspection sessions in order to provide the response related to the
compliance of the relevant quality management system.
- Identify compliance issues that require investigation while
evaluating risks and implements, according to client requirements,
corrective and preventive actions with the aim of reducing
non-conformity and observation.
- Provide technical support to the functions involved in managing
the process change control and the corrective and preventive
actions related to the compliance topics.
- Participate in the training processes for the relevant topics,
ensuring the compliance with applicable standards and procedures
while working with the HR Team and others relevant functions.
- Keep up-to-date relevant operating procedures and instructions
in order to guarantee standardization and harmonization of the
service provided in alignment with the relevant system standards
- Assist the client with the relevant documents and declaration
(such as Position Papers) explaining positions in relation to
specific topics or regulations.
- Consolidate the annual management review.
- Promptly transfer and provide the involved team with complete
and accurate data, information, reports and documentation in order
to ensure the effectively and efficiently alignment.
- Contribute effectively in the standard Technical Quality
Agreement (TQA) consolidation, keeping the content up to date and
reviewing it with respect to the quality system in place and
applicable client standards. Requirements
- Master's degree (Computer Sciences, Engineering, Informatics,
Chemistry, Biotechnology, Physics, Mathematics).
- Minimum of 4-6 years of experience.
- Knowledge of applicable regulatory requirements and standards
such as local regulatory requirements, cGMP requirements, FDA
regulations and ISO standards.
- Legal and standard requirements linked to the relevant standard
- Knowledge of technology, product, production, compliance
management system, CAPA, change deviation, internal audit, project
management, and risk management.
- Possess an analytical approach, problem-solving, risk-based
thinking approach, economic understanding, and result
mindset.Location: Indianapolis, INOur collaborators are engaged,
developed, challenged and well-rewarded for performance.We
recognize the importance of leadership at all levels of our
organization in order to succeed in a challenging business
environment, and we are committed to providing practical processes
and programs to identify, develop and inspire all our current and
Keywords: PQE Group, Indianapolis , Quality Compliance Specialist, Other , Indianapolis, Indiana
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