Quality Assurance Validation Specialist
Posted on: May 16, 2022
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
- 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
- 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
- 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
- Ability to communicate effectively with a wide range of
- 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,
- 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
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