Data Integrity Officer (DIO)
Department: Quality Assurance
Location: Monroe, NC
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Glenmark is actively seeking a Data Integrity Officer (DIO) to join the growing team in Monroe, NC. This position is responsible for ensuring the accuracy and reliability of cGMP data and data supporting regulatory submissions. Generally, this requires implementing, as appropriate, and overseeing systems and processes to ensure complete, consistent, enduring, and accessible data is attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
Responsibilities include but not limited to:
- Review and Approve the selection, validation, and implementation of software used for the generation of cGMP data
- Review and Approve the procedure for, and usage of manual data recording systems used for the generation, calculation and recording of cGMP data, ensuring all DI requirements are met.
- Assess training program and materials for adequacy to educate employees on expectations related to data integrity and conduct or oversee training, as appropriate
- Comply with applicable regulations and guidance, including, but not limited to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance
- Review and Approve that all equipment and instruments are appropriately validated, when appropriate, to protect data and ensure activities can be audited and reviewed at appropriate intervals
- Review and Approve remediation plans, retrospective assessments, and responses to regulatory audit findings related to data integrity
- Conduct audits and gap assessments based on regulatory requirements and industry guidance as updated and issued from time to time, approving all incidents and appropriate CAPA are acceptable and implemented fully.
- Within 24 hours of becoming aware of any DI incidents, to ensure a QMS event is raised and report to site leadership and reporting managers.
- Prepare and report as responsible officer, a monthly report on the DI status of the site and report for inclusion in the monthly Site Management Review.
- Bachelor-s degree or higher in Chemistry, Biotechnology, Life Sciences, Engineering or related working experiences.
- 8+ years of experience in an FDA Regulated Pharmaceutical company with at least 5 years in QA.
- Knowledge of and experience with Data Integrity, Quality, Quality Control, Computerized Systems, Good Manufacturing Practice, Good Documentation Practice, Good Laboratory Practice, and other aspects of cGMP environments
- Demonstrated leadership experience over personnel, systems, and processes
- Experience working for a multi-national/multicultural organization is a plus
Knowledge and Skills
- Excellent knowledge Data Integrity, Quality Control, Computerized Systems Relations, Performance Management, and Learning and Development
- Demonstrated ability to influence management and collaborate with others
- Strong problem-solving skills; developing creative solutions to meet objectives
- Demonstrated experience in prioritizing multiple projects / tasks at the same time, with successful results
- Experience with pre-submission audits
- Experience with FDA data integrity
Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.
Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, Brazil.
Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research-based pharmaceutical company.
- Paid time off
- 401k plus company match
- Company paid health benefits
- Onsite access to company gym
- Corporate Discount Program
- Paid Employee Referral Program
- EAP - Employee Assistance Program
- Accident Insurance
- Critical Illness Insurance
- Commuter Accounts
- Short-Term Disability
- Life and AD & D Insurance
- Whole Life Insurance
- Auto & Home Insurance
- Pet Insurance and so much more!
Our Company is an Equal Opportunity Employer committed to fostering diversity in the workplace, both in its employee workforce and in Company leadership. (minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity). Legal authorization to work in the US is required. We will also consider candidates who need sponsorship, now or in the future, to be legally employed in the US. H1B, OPT, CPT or other -temporary work authorization- candidates will be considered.
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