Job Title: IT Systems Validation QMS Consultant
*Need Local Candidate
Job Description:
This is a long term consulting opportunity with our direct client in New Brunswick, NJ for a Quality / Validation Consultant.
The primary responsibilities are in the areas of QC Lab support, GxP assessments and QMS documentation support.
IT Quality Systems Support and Administration
- Collaborate with team members and business partners in various GxP functions such as Quality Control Lab, Manufacturing, Packaging etc. to:
- Provide support on a variety of GxP applications including, but not limited to, user access management, periodic reviews and other assigned activities in line with the regulatory agency expectations and organization s SOP s,
- Perform GxP assessments as mandated by the Quality unit or Regulatory Agencies
- Resolving reported issues in a timely manner.
- Ensure that all support and administration activities are executed in alignment with regulatory expectations, 21 CFR Part 11 requirements and the organization s SOP s.
- Assist with QMS processes and documentation related to change control, impact assessments, CAPA execution and managing deviations and incidents through root cause analysis for GxP systems changes.
- Propose alternate processes, procedures and process automation pathways to streamline and increase effectiveness and efficiency of IT operations in GxP areas.
- Support regulatory, customer and other such audits from IT department.
Qualifications and Experience:
- Minimum of a Bachelor's Degree. Preference will be given to a candidate having a bachelor s degree in Life Sciences, Pharmacy, Computer Science or Computer Information Systems (CIS) or related field.
- Minimum of 5 years of experience in a similar environment.
- Proven ability to support instrumentation applications such as Empower3, LabX, FTIR, UV/Vis or similar.
- Excellent understanding of GAMP 5, 21 CFR Part 11, Computer System Validation and Quality Management System.
- Ability to multi-task, manage competing priorities and flexibility to shift workload when needed.
- Excellent written and verbal communication skills and working knowledge of Microsoft Office Applications.
- A team player with ability to work with people at all levels and diverse skill sets.