Data Integrity and Compliance Officer
Leads a multidisciplinary team of laboratory, operations, compliance, validation, quality, and engineering personnel to ensure all CGxP data is collected, protected, archived, preserved, and retrievable according to industry and regulatory guidelines. Ensures the Research/Quality Operations have awareness of Data Integrity as it relates to paper and electronic records and ensures good documentation practices for electronic and paper-based data are in place. Proficient in the application of 21CFR Part 11 and Annex 11 regulations as well as stays current with updates to these regulations.
- Ensures 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.
- Communicates actions, compliance gaps, and commitments to respective areas, including the Site Director of Quality.
- Performs 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.
- Provides 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.
- Creates/updates procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations.
- Routinely evaluates regulatory inspection documents and updates site procedures accordingly. Keeps the site aware of industry trends.
- Creates and executes Change Controls for instrumentation/equipment. Aids in establishing user requirements for equipment.
- Establishes and leads a Surveillance program to audit all GMP facilities within the site for compliance to establish documentation and data integrity standards, practices, and procedures.
- Selects and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures.
- Serves as an advisor to Research/Quality Operations for Data Integrity matters.
- Represents the company as a subject matter expert during regulatory and customer audits for Data Integrity.
- Meets with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance.
Bachelor’s Degree in Science, Engineering, or related fields
Strongly recommended to have at least 7 years experience in a regulated industry, or 5 years with related technical knowledge including data integrity related to quality control data from chromatographic systems, knowledge of laboratory instrumentation and/or operations equipment and associated computer systems and TrackWise.
Other Job Requirements:
- Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
- Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
- Experience in data review, 21CFR Part 11 instrumentation compliance as well as writing and reviewing investigations within TrackWise.
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Effective written, interpersonal, and presentation skills.
- Ability to work on multiple projects simultaneously.