Full-Time IT Analyst, CSV
Job Description
Location:Parsippany, New Jersey
Job Description
The IT Analyst, CSV is responsible for providing oversight and support for the QC Analytical and QC Microbiology Laboratory Systems and ensure compliance with 21 CFR Part 11.
Responsibilities include assurance that QC systems adhere with regulatory (GxP) and corporate requirements for the Ferring U.S. Technical Operations site (FPG). This role will be expected to provide key support for the computerized system project teams in the planning, development, review and approval of system validation and infrastructure qualification documentation and protocols. This role is also expected to lead the execution, escalate risks in a timely manner and providing periodic status reports to Stakeholders. Shall partner with System/Process Owners, Quality Department, External Vendors etc to support internal and external audits, identify and identify opportunities to improve methodologies.
- Partner with Global/Site Quality Assurance teams, external vendors, and the end user community to continuously improve, educate and reinforce data integrity and data management concepts and best practices throughout the computerized systems lifecycle.
- Partner with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program.
- Perform gap analysis of validation documentation, systems, and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Perform periodic system reviews with business and system owners.
- Report key metrics and generate or review/update computer system related policies, procedures, templates, forms, etc
- Provide active support during regulatory agency and third-party inspections
- Research new technologies, understand existing processes, and reference recognized standards and frameworks
- Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned
- Identify opportunities for continuous improvement
Qualifications
- College degree (life sciences degree preferred) or equivalent experience.
- Minimum 5 years of experience providing quality oversight for the development, testing, implementation and validation of computerized systems used by pharmaceutical companies
- In-depth knowledge of 21 CFR Part 11, Annex 11, GAMP 5 and Data Integrity concepts.
- Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required
- Excellent analytical, interpersonal and communication skills, including written and verbal communication
- Previous experience as CSV engineer for a life sciences company regulated by the FDA preferred
- In-depth understanding of industry accepted software development and validation life cycle programs and related IT controls
- Previous experience in risk-based approach to computerized system validation a plus
- This is an office-based position which requires appropriate levels of personal protective equipment (PPE) when working in GMP areas.
- Frequent repeated motions such as keyboarding is required.
- This a team and project-based position that may require occasional shift work, weekends, and holidays.
Additional Information
All your information will be kept confidential according to EEO guidelines
How to Apply
Apply here: https://smrtr.io/fDWVD https://www.ferring.com/join-us/your-career-at-ferring/ Please visit our career site for similar and more open roles Referrer: Milanie Noriega82 total views, 0 today