Validation Lead

Role - Validation Lead

Location - Raritan, NJ (Hybrid / Remote)

Pay Rate - $45/hr on W2

Key Responsibilities

• Candidates need to have hands-on experience in validating GxP GEN AI based solutions and LSMV Safety and Pharmacovigilancesystem
• Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
• Ability to manage end-end from Inventory, assessments, remediations to final dispositions;
  
  

7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources.

Specifically in the Pharmaceutical, biotechnology, or medical device industry.

• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs).
  
  

Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.

• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management
  
  

Notes:- All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance.

Benefits: Danta offers a compensation package to all W2 employees that are competitive in the industry. It consists of competitive pay, the option to elect healthcare insurance (Dental, Medical, Vision), Major holidays and Paid sick leave as per state law.

The rate/ Salary range is dependent on numerous factors including Qualification, Experience and Location.