Ensures the Quality Laboratories and Operations have awareness of Data Integrity as it relates to paper and electronic records.
Ensures good documentation practices for electronic and paper based data.
Proficient in the application of 21CFR Part 11 and Annex 11 regulations as well as stays current with updates to these regulations.
Leads a multidisciplinary team of laboratory, operations, compliance, validation, quality, and engineering personnel to ensure quality data is reported out of the Quality Control department.
The position will coordinate and facilitate meetings with cross-functional groups to discuss data integrity. This position will be responsible for ensuring operations operates under applicable regulatory policies for documentation and data integrity/guidelines as well as striving for continuous improvement. The Data Integrity Compliance Officer is the point person during regulatory audits for Data integrity and plays a major role in regulatory and customer audits to answer questions and demonstrate to auditors that necessary controls and required competencies are in place for Patheon to maintain its license to operate.
Establishes and chairs the Data Integrity Governance Team meetings.
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.
Provides assessments and status updates to aid Data Integrity Governance team's actions to maintain and proactively improve data integrity.
Ensures Governance Team deliverables are on target, properly resourced and executed as committed.
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 Governance Team aware of industry trends.
Creates and executes Change Controls for instrumentation/equipment. Aids in establishing user requirements for equipment.
Meets with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance.
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, develops and evaluates staff to ensure the efficient operation of the function. Works with and advises staff on administrative policies and procedures.
Hires, retrains, trains, and motivates a scientifically competent staff.
Direct immediate reports and DI Governance team in setting priorities and project assignments.
Assesses technical responses to questions/issues raised by regulatory agencies and customers. Serves as an advisor to Manufacturing/Quality Operations Division for Data Integrity matters.
Represents the company as a subject matter expert during regulatory and customer audits for Data Integrity.
Collaborates on projects to meet customer, business, and regulatory requirements.
Understand emergency procedures and comply with safe systems of work.
Ensure compliance with environment, health and safety rules, signage and instructions at all times.
Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.
Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
Experience in HPLC and GC data review, 21CFR Part 11 instrumentation compliance as well as writing and reviewing investigations within TrackWise.
Previous supervision or management experience is preferred.
Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
Effective written, interpersonal, and presentation skills.
Ability to work on multiple projects simultaneously.
Bachelor's Degree in Science, Engineering, or related fields.
Must 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.
Project Management, Supervision or Management experience are preferred.