Quality Lead/Lead Validation Engineer
4 weeks ago
At Verista, we're committed to empowering growth and innovation within the scientific community. Our team of experts collaborates with the world's most recognizable brands in the life science industry to solve complex business needs.
We're seeking a Quality Lead/Lead Validation Engineer to join our team, responsible for supporting the QISM group at the Client, specifically focused on IT Infrastructure and Clinical Operations areas.
This role will work closely with operational functions, DTE (IT), and other GxP QA groups to provide oversight of computerized system implementation, maintenance, and retirement used in these areas.
The successful candidate will review and approve computerized system lifecycle documentation, provide Part 11/Annex 11, and data integrity expertise to key stakeholders internal to the Client.
Key responsibilities include:
- Understanding regulations pertaining to the implementation and use of computerized systems in all GxP areas
- Participating in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy
- Reviewing and approving system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas
- Consulting with QISM team members and relevant internal stakeholders to identify high-risk areas
- Identifying and escalating areas of risk or non-compliance to manager/leadership team
- Participating in performing Periodic Review activities of Computerized Systems
- Providing support to regulatory inspection preparedness activities as needed
Requirements:
- Experience performing Infrastructure Qualification activities
- Bachelor's degree and relevant GxP work experience
- Proficiency in using Microsoft Office applications
- 8-10 years of experience performing validation activities
PREFERRED QUALIFICATIONS:
- Experience with the following:
- Performing Quality Assurance function related to Clinical Computerized Systems/Infrastructure
- Proficiency with regulations related to FDA/MHRA regulations
- Use of computerized quality management systems
- Experience with validation of Enterprise/Lab Computerized Systems
- Quality metrics, dashboards, analysis, and improvement programs
- Knowledge of GAMP and Agile validation lifecycle and methodologies
- Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the Client's organization
- Proven attention to detail and organization in project work
- Capable of working on assigned tasks without mentorship
Expert knowledge of FDA regulations, ISPE guidelines, and ISO standards including:
- Good Documentation Practice (GDP) in pharmaceutical environment
- 21 CFR Part 11
Benefits:
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness, and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
For more information about our company, please visit us at https://www.verista.com.
The salary range for this position is $87,780-$140,220. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice.
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