GxP Systems Support

Our client, a leading pharmaceutical manufacturing company, is seeking an experienced GxP Systems Support professional to join its team in New Brunswick, NJ
. This onsite contract opportunity is ideal for candidates with experience supporting GxP-regulated systems and applications within a pharmaceutical or life sciences environment. The role will support critical business functions by ensuring GxP systems remain compliant with regulatory requirements while providing technical support, system administration, and quality documentation assistance. Candidates with a strong understanding of computer system validation, quality management systems, and FDA regulations are encouraged to apply.

On-site

Contract

Pay rate:
DoE

• 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 SOPs,
• Perform GxP assessments as mandated by the Quality unit or Regulatory Agencies.
• Resolve reported issues in a compliant and a timely manner.
• Ensure that all support and administration activities are executed in alignment with regulatory expectations, 21 CFR Part 11requirements and the organization’s SOPs.
• 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.

• Minimum of a Bachelor's Degree. Preference will be given to a candidate having a bachelor’s degree inLife 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 Trackwise, Open Text D2, LMS, 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.

• May require travel to other manufacturing sites (Princeton, NJ / NY / MA) as required.

• Integrity
• Commitment
• Quality
• Diversity

• Direct deposit
• Weekly pay
• Medical benefits
• 401(k) Plan