Data Integrity Compliance Officer
This role is an exciting opportunity within our Quality function for the successful applicant to play a pivotal role ensuring operations operate under applicable regulatory policies for documentation and data integrity/guidelines as well as striving for continuous improvement. The Data Integrity Compliance Officer is the key point of contact during regulatory audits for data integrity and will play a major role in regulatory and customer audits answering questions and demonstrating to auditors that necessary controls and required competencies are in place for Patheon to maintain its license to operate.What will you do?Establish and chair the Data Integrity Governance Team meetings.
Ensure all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations.
Provide assessments and statu updates to aid Data Integrity Governance team?s actions to maintain and proactively improve data integrity.
Ensure the Governance Team deliverables are on target, properly resourced and executed as committed.
Communicate actions, compliance gaps, and commitments to respective areas, including the Site Director of Quality.
Perform risk assessments to determine high risk equipment and audit trails and take appropriate action to bring into compliance. Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase.
Provide periodic training to all operations to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices.
Create/update procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations. Routinely evaluates regulatory inspection documents and updates site procedures accordingly. Keep the Governance Team aware of industry trends.
Create and execute Change Controls for instrumentation/equipment. Aid in establishing user requirements for equipment.
Meet with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance.
Establish and lead a Surveillance program to audit all GMP facilities within the site for compliance to establish documentation and data integrity standards, practices, and procedures.
Select, develop and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures.
Hire, re-train, train and motivate scientifically competent staff.
Direct immediate reports and DI Governance team in setting priorities and project assignments.
Assess technical responses to questions/issues raised by regulatory agencies and customers. Serve as an advisor to Manufacturing/Quality Operations Division for Data Integrity matters.
Represent the company as a subject matter expert during regulatory and customer audits for Data Integrity.
Collaborate on projects to meet customer, business, and regulatory requirements.
Who we are looking for? ? Experience, skills:
An individual who is experienced in working within the Pharmaceutical industry,
Holds a Bachelor?s Degree in Science, Engineering, or related fields
Must hold related technical knowledge including data integrity related to quality control data from chromatographic systems, knowledge of manufacturing and laboratory instrumentation and/or operations equipment and associated computer systems.
Knowledge of computer system validation (CSV) principles in accordance to ISPE GAMP 5
Knowledge of MHRA ?GXP? Data Integrity Guidance and Definitions published in 2018, along with the ER/ES compliance rules stated in the regulated agency (FDA 21 CFR Part 11 and EMEA Annex 11).
Project Management, Supervision or Management experience are preferred.
Knowledge of Trackwise desired
Previous experience working/communicating with auditorsAbout us:
As the world leader in serving science, our work is more than something that fills our days. When you?re part of Thermo Fisher Scientific, you?ll do challenging work, and be part of a team that values performance, quality and innovation. With revenues of $24 billion and the largest investment in R&
D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Each one of our 70,000 extraordinary minds has a unique story to tell. It?s not just a career, it?s a chance to realise your best ? professionally and personally.Join us and contribute to our mission?enabling our customers to make the world healthier, cleaner and safer. Apply today!http: