Quality Assurance Validation Specialist

Company: PharmaLex
Location: Durham
Posted on: May 16, 2022

Job Description:

Job DescriptionJOIN 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 looking for resources to provide QA Specialist services in Durham, North Carolina. 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.Job Responsibilities

• 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.Preferred Experience, Education & Qualifications
  • MUST HAVE a Bachelor's Degree in Engineering or Life Sciences and/or equivalent industry experience.
  • MUST HAVE a 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.Powered by JazzHRwRisE6YHBz

Keywords: PharmaLex, Durham , Quality Assurance Validation Specialist, Other , Durham, North Carolina