Senior Qualification & Validation Specialist

RXinsider LTD.; New Jersey; Hybrid; USD 65,000 - 89,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401k retirement with company match

Paid time off and holidays

Job summary

QuVa is seeking a Qualification and Validation Senior Specialist in the United States to lead qualification and validation activities across sites. You will develop master plans, author protocols, support regulatory inspections, and oversee deviations and CAPAs to ensure cGMP compliance.

Ideal candidates have 5+ years of experience in pharmaceutical qualification/validation, CSV knowledge, and strong communication skills.

Qualifications

• Associate’s/Bachelor’s degree or equivalent validation experience

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 those items considered critical to meet the local requirements for qualification
• Provides technical support and guidance on process qualification and validation by authoring and reviewing protocols, identifying gaps, and establishing action plans for those items considered critical to meet the local requirements for process qualification and validation
• 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 IQ’s, OQ’s, PQ’s, 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 appropriate criteria and test cases are captured and met to be compliant with industry standards, mfg. specs and QuVa requirements
• Leads execution and provides training when applicable across sites for smoke study activities including making sure these studies capture the process and aseptic technique correctly
• Assists or leads in creating/writing Standard Operating Procedures (SOPs), Work Instructions (Wis), and Incident Reports (IR’s) for equipment and procedures related to qualification/validation activities
• Supports the proper continuous functionality of qualified/validated equipment and processes supporting the automation/facilities team when complicated issues occur
• Onboarding of equipment to include evaluating the equipment criticality
• Assists in Computer Software Validation (CSV) periodic reviews, gap assessments, and validation activities when required
• Provides training in validation and qualification concepts to all personnel involved with the execution of qualification and validation activities
• Participates in high level troubleshooting activities related to equipment and processes
• Complies with 503B guidelines, ISO standards, Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), and company policies
• Conducts investigations, root cause analyses, and develops corrective actions for non-conformances experienced during the execution of qualification and validation activities
• Provides routine communications to internal and/or external stakeholders regarding the status of qualification and validation activities
• As necessary, works with third-party service providers and contractors to ensure overall work is being done in accordance with work instructions, 503B, cGMP, GDP, training, etc.
• Provides guidance, advice, feedback and support to more junior level validation specialists
• Provides technical support and guidance on Deviations, Standard Operating Procedures (SOPs), Work Instructions (WIs), Incident Reports (IRs) related to quality
• Creates status reports and schedules for intradepartmental activities

Skills

Written communication

Verbal communication

Attention to detail

Education

Bachelor’s / Associate degree or equivalent validation experience

Tools

Microsoft Word

Microsoft Excel

Job description

QuVa is seeking a Qualification and Validation Senior Specialist in the United States to lead qualification and validation activities across sites. You will develop master plans, author protocols, support regulatory inspections, and oversee deviations and CAPAs to ensure cGMP compliance.

Ideal candidates have 5+ years of experience in pharmaceutical qualification/validation, CSV knowledge, and strong communication skills.