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Quality Assurance Validation (QAV) Specialist

PharmaLex
Durham, NC
  • Expired: January 28, 2022. Applications are no longer accepted.

JOIN OUR TEAM!

PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.

 

General Description:

We are seeking consultants who can provide support as a Quality Assurance Validation (QAV) Specialist in a Pharmaceutical and Biotechnology industry.

 

Position Summary:

Come join the enthusiastic and collaborative Quality Assurance Validation (QAV) team to contribute to the overall success of our novel gene therapy. This position will support the QAV organization through guidance and quality review/approval of internal protocols and reports related to process manufacturing equipment qualification, technology transfer, and process validation. These activities will encompass IND-enabling, pre-clinical, clinical, and commercial projects.

 

KEY RESPONSIBILITIES AND ACTIVITIES

The QAV Specialist Contractor will be responsible for supporting the QAV organization providing QA oversight in multidisciplinary areas as follows:

  • This individual will be responsible for Technology Transfer and Process Validation projects, and associated documentation included but not limited to: Plans, Risk Assessments, Protocols, and Reports.
  • Provide review and/or approval to Commissioning, Qualification and Re-qualification lifecycle documentation on Facility, QC, and Manufacturing Equipment and Systems, and included but not limited to: Requirement Specifications, Plans, Protocols, and Reports.
  • Provide QA support and review and approval for deviations, protocol exceptions and CAPAs, as needed.
  • Ensure all documentation complies with internal requirements, GMP regulations, and industry guidelines.
  • Review and approve Change Controls and associated documentation, as needed.
  • Review and/or approve Standard Operating Procedures, as needed.

 

REQUIREMENTS

  • Bachelor's Degree in Engineering or Life Sciences and/or equivalent industry experience.
  • Minimum of 10 years of total combined experience in quality assurance and/or validation within a GMP regulated manufacturing environment (FDA, EMA, MHRA).
  • Experience in upstream, downstream and/or aseptic fill/finish manufacturing.
  • Experience with qualification of equipment, utilities, facilities, and technology transfer and process validation.
  • Knowledgeable of current industry practices and regulatory expectations regarding qualification, technology transfer and validation.
  • Ability to communicate effectively with a wide range of personnel/cross-functional teams.
  • Capability to perform detailed review of GMP documents.
  • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
  • Microsoft Office, including Word, Excel, PowerPoint, Outlook.
  • Experience within a multi-product facility is a plus.
  • Experience using risk-based approaches (FMEA, PHA, etc.).
  • Strong analytical ability.
  • Ability to exercise judgment within and outside of defined procedures and practices to determine appropriate action.
  • Ability to multitask and prioritize independently in a fast paced environment.

 

PharmaLex is an Equal Opportunity Employer.

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PharmaLex

Address

Durham, NC
USA

Industry

Technology

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