Senior Qualification & Validation Expert

Quva; Bloomsbury (NJ); On-site; USD 65,000 - 89,000; Full time

Benefits offered by this job

Health and wellness benefits

401(k) retirement with company match

Paid time off and holidays

Overtime opportunities with notice

Career advancement opportunities

Job summary

QuVa is seeking a Qualification and Validation Senior Specialist to ensure high quality and safety standards across all sites in the US. You will drive compliance with Qualification and Validation policies, author and review master plans, protocols, and execution strategies, and support equipment, facilities, and process qualification and validation activities throughout the operations lifecycle.

You will lead projects, support inspections, and develop SOPs/WWIs/IRs while training staff and

Qualifications

• Associate’s/Bachelor’s degree or equivalent validation experience.
• 5 years’ Qualification and Validation experience including writing and executing protocols and commissioning documents.
• 5 years of pharmaceutical experience including knowledge of cGMP, GDP, FDA Aseptic Guidelines, ISO-14644, and other pharma regulatory requirements.
• Experience in performing smoke studies.
• Knowledge of Computer Software Validation (CSV).
• Proficient with Microsoft Word and Excel.
• Must be authorized to work in the United States on a full-time basis; No visa sponsorship.

Responsibilities

• Provides prospective evaluation, technical input, authoring, and review of qualification and validation master plans, commissioning documents, protocol content and execution strategy, ensuring compliance with corporate and regulatory standards.
• Provides technical support and guidance on equipment, facilities, and utilities qualification by authoring and reviewing protocols, identifying gaps, and establishing action plans for items critical to meet local requirements.
• Provides technical support and guidance on process qualification and validation by authoring and reviewing protocols, identifying gaps, and establishing action plans for items critical to meet local requirements.
• Provides direct support for the execution process of qualification and validation protocols.
• Supports site inspections from regulatory bodies, providing comprehensive technical background and history related to qualification and validation efforts
• Writes and executes technical documents such as IQs, OQs, PQs, Engineering Studies, Summary Reports, etc.
• Writes, evaluates, and resolves deviations that occur during protocol execution.
• Independently leads higher level projects related to qualification/validation activities across sites to ensure proper and timely completion.
• Reviews and approves protocol templates, executes protocols, and summary reports to ensure all criteria and test cases are captured and met to be compliant with industry standards, mfg. specs and QuVa requirements.
• Leads execution and provides training across sites for smoke study activities including proper process and aseptic technique.
• Assists or leads in creating/writing SOPs, Work Instructions, and Incident Reports for equipment and procedures related to qualification/validation activities.
• Supports continuous functionality of qualified/validated equipment and processes supporting automation/facilities when issues occur.
• Onboarding of equipment to include evaluating equipment criticality.
• Assists in CSV periodic reviews, gap assessments, and validation activities when required.
• Provides training in validation and qualification concepts to all personnel involved with execution of qualification and validation activities.
• Participates in high level troubleshooting activities related to equipment and processes.
• Complies with 503B guidelines, ISO standards, cGMP, GDP, and company policies.
• Conducts investigations, root cause analyses, and corrective actions for non-conformances.
• Provides routine communications to internal/external stakeholders regarding status of qualification/validation.
• Works with third-party service providers to ensure work complies with instructions, 503B, cGMP, GDP, training, etc.
• Provides guidance to junior validation specialists.

Skills

Regulatory compliance

Technical writing

Project leadership

Equipment qualification

Process validation

Troubleshooting

Communication skills

Education

Associate/Bachelor’s degree or equivalent

Tools

Laminar flow hoods

Biological safety cabinets

Room classification & control

Environmental monitoring

Controlled environment testing

CSV (Computer Software Validation)

Job description

QuVa is seeking a Qualification and Validation Senior Specialist to ensure high quality and safety standards across all sites in the US. You will drive compliance with Qualification and Validation policies, author and review master plans, protocols, and execution strategies, and support equipment, facilities, and process qualification and validation activities throughout the operations lifecycle.

You will lead projects, support inspections, and develop SOPs/WWIs/IRs while training staff and