Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

Job Description:

• Plan and prepare validation plan tests and qualification protocols for manufacturing processes, systems, equipment for production of pharmaceuticals products.
• Perform GAMP 5 risk based validation and Prepare IQ/OQ/PQ, validation plan, test cases, system/module risk assessment.
• Perform corrective and preventive actions (CAPA) in the scope of a retrospective validation. Perform risk-based prioritization and unique predefinitions of tasks.
• Maintain test results Deviation log and ensure that the deviations are closed in the stipulated time.
• Travel to various unanticipated locations in the US to interact with clients for short or long terms assignments

Salary: $125,008 /year

Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)

Requirements: BS or foreign equivalent in Pharmaceutical Sc., Biotechnology, Chemistry or related + 5 yrs of exp as Validation Analyst, QA Analyst or related, performing Gamp 5 Risk based validation and using Trackwise, HP Quality Center, and QTP 11. The Employer will also accept MS or foreign equivalent in Pharmaceutical Sc., Biotechnology, Chemistry or related + 1 yr of exp as 5t, QA Analyst or related, performing Gamp 5 Risk based validation and using Trackwise, HP Quality Center, and QTP 11

Job Location: 270 Davidson Avenue, 1^st Floor Suite 111, Somerset, NJ 08873

To apply contact: Santhosh Kinnera, IT Project Manager

hr@tk-chain.com