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Quality Compliance Specialist

Company: PQE Group
Location: Indianapolis
Posted on: June 25, 2022

Job Description:

*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 and regulations.
  • 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 applicable.
    • 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 future leaders.

Keywords: PQE Group, Indianapolis , Quality Compliance Specialist, Other , Indianapolis, Indiana

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