Senior Pharma Qualification & Validation Specialist

QuVa Pharma, Inc.; New Jersey; Hybrid; USD 65,000 - 89,000; Full time

Benefits offered by this job

Health insurance

401k program

Paid time off

Overtime opportunities

Job summary

QuVa Pharma, Inc. in Bloomsbury, NJ is seeking a Qualification & Validation Senior Specialist to drive qualification and validation activities across sites. You will develop master plans, write and review protocols, and support regulatory compliance to ensure product quality and patient safety.

The role requires 5 years of qualification/validation experience, knowledge of cGMP/GDP, and the ability to lead cross-site projects. On-site work with occasional collaboration across facilities.

Qualifications

• 5 years of Qualification and Validation experience including writing and executing protocols and commissioning documents.
• Experience with cGMP, GDP, FDA Aseptic Guidelines, ISO-14644 and regulatory requirements.
• Experience in performing smoke studies and knowledge of CSV.
• Proficient with Microsoft Word and Excel.

Responsibilities

• Provides prospective evaluation, technical input, authoring, and review of qualification and validation master plans and commissioning documents.
• Authoring and reviewing protocols for qualification and validation and identifying gaps.
• Leading execution of qualification and validation protocols and supporting site inspections by regulators.
• Writes and reviews Deviation reports and maintains test records to ensure compliance.

Skills

Qualification & Validation

Protocol writing

Regulatory compliance

Troubleshooting

Communication

Team leadership

Education

Associate/Bachelor's degree

Tools

CSV

Microsoft Word

Microsoft Excel

Job description

QuVa Pharma, Inc. in Bloomsbury, NJ is seeking a Qualification & Validation Senior Specialist to drive qualification and validation activities across sites. You will develop master plans, write and review protocols, and support regulatory compliance to ensure product quality and patient safety.

The role requires 5 years of qualification/validation experience, knowledge of cGMP/GDP, and the ability to lead cross-site projects. On-site work with occasional collaboration across facilities.