Sr. IT Compliance Analyst
General Position Summary/Purpose:
The Sr. IT Compliance Analyst will be responsible for providing Compliance for of IT Systems, Audit Remediation, and SOP authoring supporting various IT client organization including but not limited to Manufacturing, Quality Control, and R&D business units. The individual will provide support to ensure Change management, CAPA, Deviations, training, Good Documentation practices, SOP and IT systems reviews are conducted in accordance with established policies and procedures. The individual will collect and maintain Quality metrics to support IT controls across the entire IT organization and, to support Regulatory Audits and Inspection Readiness. In addition, the individual will have hands on experience with supporting Internal and External audit exercise. The individual must have hands-on experience in the Biotechnology/Pharmaceutical FDA regulated industry.Key Accountabilities / Core Job Responsibilities:
Provide assistance in performing periodic reviews by working with onsite and offshore QA and Compliance resources.
Provide assistance conducting IT vendor/supplier audits and adherence to company policies and procedures
Assist in the identification, collection, and management of GXP Quality Metrics related to various Pharmacyclics IT control areas.
Assist in the creation and maintenance of policies, procedures, and other guidance documents that provide compliance to internal and external IT controls.
Ensures IT procedures are following regulatory and corporate requirements.
Ensures IT personnel are operating in compliance with regulations and procedures.
Assists IT personnel in interactions with Quality Assurance personnel and the Quality Management Systems.
Evaluates, develops, and modifies IT Policies and Standard Operating Procedures to meet regulatory requirements and obligations by providing technical writing assistance.
Works closely with validation team to ensure IT Infrastructure and systems are qualified, validated and maintained in a validated state.
Assists IT Compliance Manager and IT Subject Matter Experts (SMEs) during internal and external audits.
Ensures IT operational controls are in place and maintained throughout the system lifecycle (e.g. periodic reviews, disaster recovery testing, performance monitoring etc.).
Tracks and verifies that all IT Administration and control activities are completed as per procedures.
Champions Good Documentation Practices in support of Data Integrity, Data Security for all IT systems.
Assists IT personnel in writing/responding to deviations/events including detailed event investigation and root cause analysis.
Tracks and facilitates the remediation activities associated with IT-related CAPAs and other Quality records. Completes GAP assessment and remediation efforts.
Ensures IT training is adequate and current.
Track and ensure completion of Audit and Inspection related findings are completed on time
Strong knowledge of IT Controls and Audit processes and applications Knowledge of procedures and best practices related to FDA, EMA, GxP, CFR21 Part 11, Computer System Validation, and other regulations governing drug development and commercialization.
Demonstrated knowledge of FDA audit procedures and IT Quality system validation best practices.
Ability to assist in documenting and providing audit response to internal and external audits in a timely fashion
Familiarity with SDLC in the FDA regulated Biotechnology/Pharmaceutical industry is necessary.
Bachelor's Degree in Computer Science, Information Technology, or related discipline.
5+ years of pharmaceutical GxP system validation experience.
Excellent communication, presentation, and documentation skills with strong attention to detail and well organized.
Experience with conducting risk assessment and knowledge of current industry good practice for risk assessment methodologies and tools, e.g., GAMP, NIST, ICH Q9)
Experience with application of CAPA methodology including structured approach for failure investigation and identification of root cause.