IT Compliance Analyst
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
#SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job summary
The IT Compliance Analyst supports the quality and compliance activities within the Information Technology (IT) department. The primary responsibilities will include managing IT’s Computer System Validation (CSV) Programs to lead and oversee site validation activities ensuring compliance with internal company validation procedures and industry regulations for validation activities.
The ideal candidate will have knowledge and experience in the area of Good Clinical Practices (GCPs) guidance and applicable clinical regulations, including FDA 21 CFR part 11, as related to developing, implementing, validating, maintaining and supporting assigned computerized systems in order to endure that operations are implemented and maintained in a compliant state.
Job responsibilities
Manage and/or coordinate the writing and execution of validation protocols, specifications, change controls and/or scripts related to software, instruments and/or equipment according to the organization’s compliance requirements and industry regulations.
Provide support for Information Technology’s project portfolio within assigned projects, ensuring that technology solutions are classified in accordance with set standards, implemented to support those standards within agreed upon timelines.
Coordinate assigned project deliverables with external consultants and suppliers concerning the implementation, validation, support and maintenance to ensure these activities are completed in alignment with standard compliance principles.
Serve as subject matter expert in specialized project area to support client and regulatory agency audits and inspections for Information Technology activities.
Lead compliance efforts for any corrective or preventative actions plans supporting assigned Information Technology solutions.
Execute harmonization of compliance activities to support mergers, acquisitions and internal expansion of the compliance program.
Act as a compliance resource expert to other groups.
Assist internal clients with requests and problem resolution, participate in the maintenance of documentation and make recommendations for greater effectiveness in functional area of compliance
Make recommendations for continued improvement in the area of compliance for Information Technology.
Perform training in the principles of computerized systems validation for internal personnel.
Conduct periodic reviews of validation documentation to ensure systems continue to operate in a validated state, and perform impact assessments on planned GxP and Business Critical Change Management requests.
Perform quality reviews of validation deliverables.
Qualifications
Bachelor’s Degree in Computer Science or related science field or equivalent.
4-6 Years of experience in IT Compliance, CSV.
Domain knowledge in Life science /Pharmaceutical/CRO
Experience with 21 CFR Part 11 required.
Experience in computer systems validation/software development life cycle approaches.
Experience in working in a clinical trials environment, including a comprehensive knowledge of GCP regulations Guidelines.
Effective verbal and written communication
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