Data Integrity Specialist

工作内容

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Due to our constant growth, we are looking for a Data Integrity Specialistto support our projects in Taiwan.

You will be responsible for

• Support in the Validation Life Cycle of Computerized Systems with special attention to the SAP system, laboratory systems (LDA’s) and production control systems: Drafting of Validation Plans; Drafting and Review of Specification documentation.
• Specification of User Requirements.
• Risk Analysis.
• Drafting of DQ, IQ, OQ and PQ testing protocols.
• Execution of validation tests and the phase reports.
• Provider support during systems implementation.
• Drafting and Review of Standard Operating Procedures (SOP).
• Acting of IT/QA Compliance: Evaluation of the State of compliance of the Computerized Systems with respect to the requirements of Data Integrity. Proposal for remedial actions based on the level of risk associated with the GAPs found.
• Support and execution of Data Integrity Compliance remediation actions on Laboratory and Production Systems.
• Review of generated validation documentation.
• Preparation/updating of Policies, SOPs, Standards and Validation Templates regarding standards and Corporate Policies.
• Review of Validation documentation regarding compliance with SOPs and approved validation standards.

About you

• +5 years of experience in a similar role (PM)
• Resource preferably from Taiwan, or in any case without passport problems to enter Taiwan (possibly not Chinese)
• at least three months of availability (could be more)
• GxP normative knowledge
• Drafting/Execution of Protocols (IQ/OQ)
• Fluency in English(at least B2) both in writing and speaking, Mandarin language not mandatory but good to know
• Adaptability is necessary to work at the client’s site as per project-specific needs
• Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11, ...)
• Ability to work as a team player in a consulting environment

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world.

If you are looking for arewarding and exciting career, PQE Group is the perfect place for you.

Apply now and take the first step towards an amazing future with us.