Nature of the Position:
Reporting in to the Quality department, the Data Integrity position is responsible for driving the implementation of an effective GxP Data Integrity Governance Program (the Program) to ensure that regulatory and company requirements are addressed in a thorough effective, and timely manner.
- Drive implementation of Data Integrity Governance Program milestones through coordination and execution of cross-functional deliverables.
- Write and/or edit procedural documentation and training materials to ensure an ongoing state of Data Integrity compliance across the cGxP product lifecycle, and internal functions.
- Responsible for oversight of all data integrity matters; perform data integrity related review of cGMP documents for Operations and Quality and assist the site in the closure of data integrity related discrepancies.
- Ensure entire site personnel are trained on data integrity requirements and compliance.
- Review paper and electronic documents related to cGMP activities for verifying the compliance against data reliability requirements.
- Responsible for the oversight of cGMP areas and for verifying the compliance against data reliability requirements.
- Manage, implement and coordinate quality assurance program to prevent or minimize risk to the integrity of data at the manufacturing site.
- Provide independent oversight to the data integrity program for the facility including data generation and review. Identify and document discrepancies by following applicable procedures.
- Communicate discrepancies to responsible personnel at the site to ensure compliance.
- Assist the respective site personnel to ensure compliance of data reliability related to observations.
- Identify areas where data reliability training is needed and provide appropriate training as required to the site personnel.
- Prepare data reliability documents for Operations and Quality Control.
- Maintain documentation related to data reliability review.
- Improve self-awareness and site awareness for data reliability related requirements, policies and procedures through reading of SOPs, guidelines and training.
- Other duties as assigned by management.
- Bachelor’s Degree in Science related field with an emphasis in Computer Science preferred.
- 3 - 5 years’ work experience within the GMP environment
- Hands on experience with chromatography assays (HPLC) and proficient with Water’s Empower Software for data acquisition, processing, and reporting an asset.
- cGMP, technical training and troubleshooting experience.
- Knowledge of applicable parts of 21 CFR Part 11, Eudralex Volume 4 Annex 11 regulations
- Experience with data analysis, quality, validation and IT solutions
- Knowledgeable in data profiling, root cause analysis, and quality improvement
- A combination of equivalent education and pertinent, progressive experience with increasing levels of responsibility may be considered acceptable to meet the minimal requirements.
Specific Skills Required:
- Demonstrated thorough knowledge and understanding of Governmental requirements related to Good Manufacturing Practices (cGMP), Health Canada and other legislation regulating the production operation.
- PC proficiency using Microsoft Office required.
- Outstanding oral communication and conflict resolution skills with all levels of the organization.
- Ability to think critically and apply critical thinking processes to data reliability investigations.
- Highly organized and able to work comfortably with accelerated work pace.
- Ability to work in a team or matrix environment.
- Ability to collaborate and coordinate with internal and external depts./groups/resources.
- Analytical problem solving skills.
- Ability in handling multiple and complex responsibilities, tasks and projects simultaneously.
Job Type: Full-time
- work experience within the GMP environment: 5 years (Preferred)